Who is the manufacturer of REPROCESSED ELECTROPHYSIOLOGY CATHETERS?

Ascent Healthcare Solutions filed the 510(k) submission for REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K081329).

What is the FDA product code for REPROCESSED ELECTROPHYSIOLOGY CATHETERS?

NLH. It is classified under 21 CFR 870.1220 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for REPROCESSED ELECTROPHYSIOLOGY CATHETERS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for REPROCESSED ELECTROPHYSIOLOGY CATHETERS?

Inquiry™ AFocus™ (K042775); Inquiry™ AFocusII™ (K010471); Inquiry™ Optima™ Steerable Electrophysiology Catheter (K990958); IBI-1100 Bi-directional Steerable Electrophysiology Catheter (K982232); IBI-1100 Steerable Electrophysiology Catheter (K961924); IBI-1000™ Electrophysiology Catheter (K946333).

Who can help prepare an FDA 510(k) submission like REPROCESSED ELECTROPHYSIOLOGY CATHETERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K081329 · Ascent Healthcare Solutions · NLH · Jul 9, 2008 · Cardiovascular

Device Facts

Record ID	K081329
Device Name	REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Applicant	Ascent Healthcare Solutions
Product Code	NLH · Cardiovascular
Decision Date	Jul 9, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Device Story

Reprocessed Electrophysiology (EP) Catheters are diagnostic devices used to transmit electrical impulses for endocardial recording or stimulation. The device consists of a hand piece, a flexible shaft, and a distal tip containing diagnostic electrodes. For deflectable models, the distal tip is manipulated via the hand piece to achieve a specific curve. The device is used by clinicians in a clinical setting to map cardiac structures. The output consists of electrical signals captured by the electrodes, which are used by the physician to assess cardiac electrophysiology and guide clinical decision-making. Reprocessing involves cleaning, decontamination, and functional testing of previously used catheters to restore them to original performance specifications.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of the reprocessing process, sterilization validation, functional testing, and packaging validation to demonstrate that the reprocessed catheters perform as originally intended.

Technological Characteristics

The device consists of a hand piece, flexible shaft, and distal tip with diagnostic electrodes. Materials and mechanical design are identical to the predicate devices. The device is a passive electrode recording catheter. No energy source is internal; it interfaces with external recording/stimulation equipment. Sterilization is performed as part of the reprocessing validation.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures in patients requiring diagnostic electrophysiology procedures.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

Inquiry™ AFocus™ (K042775)
Inquiry™ AFocusII™ (K010471)
Inquiry™ Optima™ Steerable Electrophysiology Catheter (K990958)
IBI-1100 Bi-directional Steerable Electrophysiology Catheter (K982232)
IBI-1100 Steerable Electrophysiology Catheter (K961924)
IBI-1000™ Electrophysiology Catheter (K946333)

Related Devices

K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS · Ascent Healthcare Solutions · Sep 16, 2008
K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS · Ascent Healthcare Solutions · Apr 1, 2009
K043393 — REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS · Alliance Medical Corp. · Mar 23, 2005
K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS · Alliance Medical Corp. · Nov 16, 2005
K030026 — REPROCESSED ELECTROPHYSIOLOGY CATHETER · Alliance Medical Corp. · May 2, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ ## JUL - 9 2008 ### SECTION 5: 510(k) SUMMARY 12/2 Ascent Healthcare Solutions Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Katie Bray Contact: Regulatory Affairs Manager (480) 763-5300 (o) (480) 763-6089 (f) mbarton@ascenths.com Date of preparation: May 9, 2008 Trade/Proprietary Name: Reprocessed Electrophysiology Name of device: Catheters Classification Name: Electrode recording catheter or electrode recording probe Manufacturer 510{k) Title Predicate Device Inquiry™ AFocus ™, Inquiry ™ Irvine Biomedical K042775 AFocusII™, or Inquiry™ Optima™ Steerable Electrophysiology Catheter Irvine Biomedical Inquiry™ AFocus™ Steerable K010471 Electrophysiology Catheter Irvine Biomedical Orthogonal™ Steerable K990958 Electrophysiology Catheter Irvine Biomedical 1BI-1100 Bi-directional Steerable K982232 Electrophysiology Catheter IBI-1100 Steerable Electrophysiology Irvine Biomedical K961924 Catheter Irvine Biomedical IBI-1000™ Electrophysiology K946333 Catheter Diagnostic Electrophysiology (EP) Catheters are specially Device description: designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece. Reprocessed Electrophysiology Catheters are intended for Indications for Use: temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The design, materials, and intended use of Reprocessed Technological Electrophysiology Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed Electrophysiology Catheters is identical to the predicate devices Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k) Page 13 K081329 {1}------------------------------------------------ K081329 in that the same standard mechanical design, materials, and in that the cultilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions' reprocessing of Electrophysiology Catheters includes removal of adherent visible soil and decontamination. Each individual Electrophysiology Catheter is tested for appropriate function of its components prior to packaging and labeling operations. ### Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters. This included the following tests: - Biocompatibility . - Validation of reprocessing . - Sterilization Validation . - Function test(s) . - Packaging Validation . Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended. ### Conclusion: Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three horizontal lines extending from its arm. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 9 2008 Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Manager, 10232 South 51st Street Phoenix, AZ 85044 Re: K081329 Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Codc: NLH Dated: May 9, 2008 Received: May 12, 2008 Dear Ms. Bray: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Pagc 2 - Ms. Katie Bray Please be advised that FDA's issuance of a substantial cquivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Bram D. Zuckerman, M Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Page 3 - Ms. Katie Bray # List of Models Found SE: | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | |-------------|------------------------------------|-----------------------------------------|------------------|-------------------|--------------------------------------|--------------------------------| | 80001 | 1010-6-25-J | Inquiry Fixed Curve | 10 | 6F | 2-5-2 mm | Josephson | | 80002 | 1010-6-25-C | Inquiry Fixed Curve | 10 | 6F | 2-5-2 mm | Cournand | | 80003 | 1010-6-28-SC | Inquiry Fixed Curve | 10 | 6F | 2-8-2 mm | Special | | 80051 | 1010-5-2-J | Inquiry Fixed Curve | 10 | 5F | 2 mm | Josephson | | 80052 | 1010-5-25-J | Inquiry Fixed Curve | 10 | 5F | 2-5-2 mm | Josephson | | 80055 | 1010-5-25-C | Inquiry Fixed Curve | 10 | 5F | 2-5-2 mm | Cournand | | 80063 | 1010-5-28-C | Inquiry Fixed Curve | 10 | 5F | 2-8-2 mm | Special Curve | | 80064 | 1010-5-28-SC(60) | Inquiry Fixed Curve | 10 | 5F | 2-8-2 mm | Special Curve | | 80065 | 1010-5-25-SC(60) | Inquiry Fixed Curve | 10 | 5F | 2-5-2 mm | Special Curve | | 80116 | 1010-6-2-J-TE4BE4 | Inquiry Fixed Curve | 10 | 6F | 2 mm | Josephson | | 80131 | 1010-4-5-C | Inquiry Fixed Curve | 10 | 4F | 5 mm | Cournand | | 80132 | 1010-4-5(10)5-J1 | Inquiry Fixed Curve | 10 | 4F | 2-5-2 mm | Cournand | | 80133 | 1010-4-2-J | Inquiry Fixed Curve | 10 | 4F | 2 mm | Josephson | | 80134 | 1010-4-5-J | Inquiry Fixed Curve | 10 | 4F | 5 mm | Josephson | | 80135 | 1010-4-25-J | Inquiry Fixed Curve | 10 | 4F | 2-5-2 mm | Josephson | | 80137 | 1010-4-5(50)-J1 | Inquiry Fixed Curve | 10 | 4F | 5(50)5 mm | Josephson 1 | | 80138 | 1010-4-5(10)-J1 | Inquiry Fixed Curve | 10 | 4F | 5(50)5 mm | Josephson 1 | | 80139 | 1010-6-28-SC(SOFT) | Inquiry Fixed Curve | 10 | 6F | 2-8-2 mm | Special | | 80405 | 1004-6-25-J | Inquiry Fixed Curve | 4 | 6F | 2-5-2 mm | Josephson | | 80406 | 1004-6-5-C | Inquiry Fixed Curve | 4 | 6F | 5 mm | Josephson | | 80407 | 1004-6-2-7 | Inquiry Fixed Curve | 4 | 6F | 2 mm | Cournand | | 80408 | 1004-6-5-J | Inquiry Fixed Curve | 4 | 6F | 2-5-2 mm | Cournand | | 80409 | 1004-6-5-C | Inquiry Fixed Curve | 4 | 6F | 5 mm | Cournand | | 80411 | 1004-6-25-D | Inquiry Fixed Curve | 4 | 6F | 2-5-2 mm | Domato | | 80412 | 1004-6-5-D | Inquiry Fixed Curve | 4 | 6F | 5 mm | Domato | | 80413 | 1004-6-10-J | Inquiry Fixed Curve | 4 | 6F | 10 mm | Josephson | | 80414 | 1004-6-10-C | Inquiry Fixed Curve | 4 | 6F | 10 mm | Cournand | | 80415 | 1004-6-10-D | Inquiry Fixed Curve | 4 | 6F | 10 mm | Damato | | 80440 | 1004-5-5- C(HIS)(SOFT) | Inquiry HIS Fixed Curve | 4 | 5F | 5 mm | Cournand | | 80451 | 1004-5-2-J | Inquiry Fixed Curve | 4 | 5F | 2 mm | Josephson | | 80452 | 1004-5-25-J | Inquiry Fixed Curve | 4 | 5F | 2-5-2 mm | Josephson | | 80453 | 1004-5-5-J | Inquiry Fixed Curve | 4 | 5F | 5 mm | Josephson | | 80455 | 1004-5-25-C | Inquiry Fixed Curve | 4 | 5F | 2-5-2 mm | Cournand | | 80456 | 1004-5-5-C | Inquiry Fixed Curve | 4 | 5F | 5 mm | Cournand | | 80458 | 1004-5-25-C | Inquiry Fixed Curve | 4 | 5F | 2-5-2 mm | Damato | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 80459 | 1004-5-5-D | Inquiry Fixed Curve | 4 | 5F | 5 mm | Domato | | 80463 | 1004-5-10-C | Inquiry Fixed Curve | 4 | 5F | 10 mm | Cournand | | 80464 | 1004-4-2-C | Inquiry Fixed Curve | 4 | 4F | 2 mm | Cournand | | 80465 | 1004-4-5-C | Inquiry Fixed Curve | 4 | 4F | 5 mm | Cournand | | 80466 | 1004-4-25-C | Inquiry Fixed Curve | 4 | 4F | 2-5-2 mm | Cournand | | 80467 | 1004-4-2-J | Inquiry Fixed Curve | 4 | 4F | 2 mm | Josephson | | 80468 | 1004-4-5-J | Inquiry Fixed Curve | 4 | 4F | 5 mm | Josephson | | 80469 | 1004-4-25-J | Inquiry Fixed Curve | 4 | 4F | 2-5-2 mm | Josephson | | 80473 | 1004-5-5J(SOFT) | Inquiry Fixed Curve | 4 | 5F | 5 mm | Josephson | | 80476 | 1004-5-5-C (SOFT) | Inquiry Fixed Curve | 4 | 5F | 5 mm | Cournand | | 80479 | 1004-5-5-D(SOFT) | Inquiry Fixed Curve | 4 | 5F | 5 mm | Domato | | 80484 | 1004-5-5-J1-TE1BE2 | Inquiry Fixed Curve | 4 | 5F | 5 mm | Josephson 1 | | 80485 | 1004-4-5-J1 | Inquiry Fixed Curve | 4 | 4F | 5 mm | Josephson 1 | | 80501 | 1005-6-25-C | Inquiry Fixed Curve | 5 | 6F | 2-5-2 mm | Cournand | | 80508 | 1005-6-25-J | Inquiry Fixed Curve | 5 | 6F | 2-5-2 mm | Josephson | | 80516 | 1004-6-2-C(SOFT) | Inquiry Fixed Curve | 4 | 6F | 2 mm | Cournand | | 80517 | 1004-6-25-J(SOFT) | Inquiry Fixed Curve | 4 | 6F | 2-5-2 mm | Josephson | | 80518 | 1004-6-5-J1(SOFT) | Inquiry Fixed Curve | 4 | 6F | 10 mm | Josephson 1 | | 80519 | 1004-6-10-D(SOFT) | Inquiry Fixed Curve | 4 | 6F | 10 mm | Damato | | 80520 | 1004-6-10-C(SOFT) | Inquiry Fixed Curve | 4 | 6F | 10 mm | Cournand | | 80533 | 1010-5-28-SC(SOFT) | Inquiry Fixed Curve | 10 | 5F | 2-8-2 mm | Special | | 80534 | 1010-5-5(30)5- C(SOFT) | Inquiry Fixed Curve | 10 | 5F | 5(30)5 | Cournand | | 80535 | 1004-4-25-J1 | Inquiry Fixed Curve | 4 | 4F | 2-5-2 mm | Josephson 1 | | 80536 | 1004-4-5-D | Inquiry Fixed Curve | 4 | 4F | 5 mm | Damato | | 80537 | 1004-6-10-J(SOFT) | Inquiry Fixed Curve | 4 | 6F | 10 mm | Josephson | | 80544 | 1010-5-28-C(SOFT) | Inquiry Fixed Curve | 10 | 5F | 2-8-2 mm | Cournand | | 80567 | 1004-4-5-C(HIS) | Inquiry HIS Fixed Curve | 4 | 4F | 5 mm | Cournand | | 80602 | 1006-6-25-J | Inquiry Fixed Curve | 6 | 6F | 2-5-2 mm | Josephson | | 80603 | 1006-6-5-J | Inquiry Fixed Curve | 6 | 6F | 5 mm | Josephson | | 80604 | 1006-6-2-C | Inquiry Fixed Curve | 6 | 6F | 2 mm | Cournand | | 80606 | 1006-6-5-C | Inquiry Fixed Curve | 6 | 6F | 5 mm | Cournand | | 80627 | 1006-5-5-J1 (SOFT) | Inquiry Fixed Curve | 6 | 5F | 5 mm | Josephson 1 | | 80803 | 1008-6-5-J | Inquiry Fixed Curve | 8 | 6F | 5 mm | Josephson | | 80804 | 1008-6-2-C | Inquiry Fixed Curve | 8 | 6F | 2 mm | Cournand | | 80806 | 1008-6-5-D | Inquiry Fixed Curve | 8 | 6F | 5 mm | Damato | | 80810 | 1008-6-5-C | Inquiry Fixed Curve | 8 | 6F | 5 mm | Cournand | | 80820 | 1008-5-5-(20)5-C(HIS) | Inquiry HIS Fixed Curve | 8 | 5F | 20(5) mm | Cournand | | 80900 | 1014-7-3(70)-TE2BE2 | Inquiry Fixed Curve | | | 3-3-3-3-3- 3-70-3-3-3- 3-3-3mm | Cournand | | Item No. | Description | Trade Name | 14 Electrodes | 7F French Size | Electrode Spacing | Curve Type | | 81101 | 1110-6-2-F | Inquiry Steerable Curves | 10 | 6F | 2 mm | Med 3.2 cm | | 81102 | 1110-6-25-M | Inquiry Steerable Curves | 10 | 6F | 2-5-2 mm | Med 3.2 cm | | 81104 | 1110-6-25-L | Inquiry Steerable Curves | 10 | 6F | 2-5-2 mm | Large 4.1 cm | | 81105 | 1110-6-25-XL | Inquiry Steerable Curves | 10 | 6F | 2-5-2 mm | X-Large 5.0 cm | | 81106 | 1110-6-25-F | Inquiry Steerable Curves | 10 | 6F | 2-5-2 mm | Far Reach | | 81107 | 1110-6-5-L | Inquiry Steerable Curves | 10 | 6F | 5 mm | Large | | 81108 | 1110-6-2-L | Inquiry Steerable Curves | 10 | 6F | 2 mm | Large | | 81109 | 1110-6-2-L-TE2BE2 | Inquiry Steerable Curves | 10 | 6F | 2 mm | Large | | 81110 | 1110-6-17-H | Inquiry H Steerable Atrial | 10 | 6F | 1 & 7 mm | H | | 81120 | 1120-7-17-H | Inquiry H Steerable Atrial | 20 | 7F | 1 & 7 mm | H | | 81121 | 1121-7-17-H-SC | Inquiry H Steerable Atrial | 21 | 7F | 1-7-1 mm | H-SC | | 81124 | 1124-7-271-H | Inquiry H Steerable Atrial | 24 | 7F | 2-7-1 mm | H | | 81125 | 1106-6-27-H | Inquiry H Steerable Atrial | 6 | 6F | 2-7-2 mm | H | | 81126 | 1110-6-291-HL | Inquiry H Steerable Atrial | 10 | 6F | 2-9-1 mm | HL | | 81128 | 1121-7-5-H-UP | Inquiry H Steerable Atrial | 21 | 7F | 5 mm | H | | 81130 | 1120-7-19-HL | Inquiry H Steerable Atrial | 20 | 7F | 1 & 9 mm | HL | | 81131 | 1121-7-19-HL-SC | Inquiry H Steerable Atrial | 21 | 7F | 1-9-1 mm | HL-SC | | 81134 | 1124-7-291-HL | Inquiry H Steerable Atrial | 24 | 7F | 2-9-1 mm | HL | | 81136 | 1120-7-5-HL-UP | Inquiry H Steerable Atrial | 20 | 7F | 5 mm | HL | | 81142 | 1106-6-27-HL | Inquiry H Steerable Atrial | 6 | 6F | 2-7-2 mm | HL | | 81150 | 1124-7-271-H-SCE | Inquiry H Steerable Atrial | 24 | 7F | 2-7-1 mm | H-SCE | | 81171 | 1110-5-2-M | Inquiry Steerable Curves | 10 | 5F | 2 mm | Med 3.2 cm | | 81172 | 1110-5-25-M | Inquiry Steerable Curves | 10 | 5F | 2-5-2 mm | Med 3.2 cm | | 81174 | 1110-5-25-L | Inquiry Steerable Curves | 10 | 5F | 2-5-2 mm | Large 4.1 cm | | 81176 | 1110-5-25-L | Inquiry Steerable Curves | 10 | 5F | 2-5-2 mm | Far Reach | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 81177 | 1110-5-5-L | Inquiry Steerable Curves | 10 | 5F | 5 mm | Large 4.1 cm | | 81178 | 1110-5-2-L | Inquiry Steerable Curves | 10 | 5F | 2 mm | Large 4.1 cm | | 81179 | 1110-5-2-E | Inquiry Steerable Curves | 10 | 5F | 2 mm | Extended Reach | | 81202 | 1120-7-2-10-XXL | Ten-Ten Duodecapolar | 20 | 7F | 2-10 mm | XX Large 4.8 cm | | 81203 | 1110-5-25-M(80)SOFT | Inquiry Soft Tip Steerable | 10 | 5F | 2-5-2 mm | Med 3.2 cm | | 81207 | 1120-7-5-SL | Ten-Ten Duodecapolar | 20 | 7F | 5 mm | Super Lrg 5.1 cm | | 81209 | 1120-7-25-SL | Ten-Ten Duodecapolar | 20 | 7F | 2-5 mm | Super Lrg 5.1 cm | | 81211 | 1120-7-2(20)2(25)2-SL | Ten-Ten Duodecapolar | 20 | 7F | 2(20)2(25)2 mm | Super Lrg 5.1 cm | | 81223 | 1110-5-2(20)3-XL | Inquiry Steerable Curves | 10 | 5F | 2(50)3 | x-large | | 81401 | 1104-6-5-S | Inquiry Steerable Curves | 4 | 6F | 5 mm | Small 2.7 cm | | 81402 | 1104-6-25-M | Inquiry Steerable Curves | 4 | 6F | 2-5-2 mm | Medium 3.2 cm | | 81403 | 1104-6-5-M | Inquiry Steerable Curves | 4 | 6F | 5 mm | Medium 3.2 cm | | 81404 | 1104-6-25-L | Inquiry Steerable Curves | 4 | 6F | 2-5-2 mm | Large 4.2 cm | | 81405 | 1104-6-5-L | Inquiry Steerable Curves | 4 | 6F | 5 mm | Large 4.2 cm | | 81406 | 1104-6-25-E | Inquiry Steerable Curves | 4 | 6F | 2-5-2 mm | Extended Reach | | 81407 | 1104-6-25-F | Inquiry Steerable Curves | 4 | 6F | 2-5-2 mm | Far Reach | | 81412 | 1104-6-2-E | Inquiry Steerable Curves | 4 | 6F | 2 mm | Extended Reach | | 81417 | 1104-6-5-XL | Inquiry Steerable Curves | 4 | 6F | 5 mm | X-Large 5.0 cm | | 81418 | 1104-6-25-XL | Inquiry Steerable Curves | 4 | 6F | 2-5-2 mm | X-Large 5.0 cm | | 81471 | 1104-5-5-S | Inquiry Steerable Curves | 4 | 5F | 5 mm | Small 2.7 cm | | 81472 | 1104-5-25-M | Inquiry Steerable Curves | 4 | 5F | 2-5-2 mm | Med 3.2 cm | | 81473 | 1104-5-5-M | Inquiry Steerable Curves | 4 | 5F | 5 mm | Med 3.2 cm | | 81474 | 1104-5-25-L | Inquiry Steerable Curves | 4 | 5F | 2-5-2 mm | Large 4.1 cm | | 81475 | 1104-5-5-L | Inquiry Steerable Curves | 4 | 5F | 5 mm | Large 4.1 cm | | 81478 | 1104-5-2-S | Inquiry Steerable Curves | 4 | 5F | 2 mm | Small 2.7 cm | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 81479 | 1104-5-25-S | Inquiry Steerable Curves | 4 | 5F | 2-5-2 mm | Small 2.7 cm | | 81483 | 1104-5-5- E(HIS)(SOFT) | Inquiry IIIS Steerable Curve | 4 | 5F | 5 mm | Extended | | 81484 | 1104-5-5-L(EX- HIS)(SOFT) | Inquiry HIS Steerable Curve | 4 | 5F | 5 mm | Large | | 81485 | 1104-5-5-E(EX- HIS)(SOFT) | Inquiry HIS Steerable Curve | 4 | 5F | 5 mm | Extended | | 81503 | 1104-6-5-L-TE2BE2- BD | Inquiry Bi-Directional | 4 | 6F | 5 mm | Large 4.1 cm | | 81504 | 1110-6-5-M-TE2BE2- BD | Inquiry Bi-Directional | 10 | 6F | 5 mm | Med 3.2 cm | | 81511 | 1105-6-25-M | Inquiry Steerable Curves | 6 | 6F | 2-5-2 mm | Med 3.2 cm | | 81520 | 1110-6-2-XL-TE4BE4 | Inquiry Steerable Curves | 10 | 6F | 2 mm | X-Large 5.0 cm | | 81521 | 1105-5-5(170)-M/L- TE1BE2(SOFT) | Inquiry Soft Tip Steerable | 5 | 5F | 5(170) | Med/Large | | 81524 | 1110-6-2-L-TE4BE4 | Inquiry Steerable Curves | 10 | 6F | 2 mm | Large 4.1 cm | | 81530 | 1110-4-2-M | Inquiry Steerable Curves | 10 | 4F | 2 mm | Med 3.2 cm | | 81531 | 1110-4-25-M | Inquiry Steerable Curves | 10 | 4F | 2-5-2 mm | Med 3.2 cm | | 81532 | 1110-4-025-L | Inquiry Steerable Curves | 10 | 4F | 2-5-2 mm | Large 4.1 cm | | 81534 | 1110-4-5-L | Inquiry Steerable Curves | 10 | 4F | 5 mm | Large 4.1 cm | | 81536 | 1110-4-25-M(80) | Inquiry Steerable Curves | 10 | 4F | 2-5-2 mm | Med 3.2 cm | | 81537 | 1110-4-25-M(SC)(60) | Inquiry Steerable Curves | 10 | 4F | 2-5-2 mm | Med 3.2 cm | | 81540 | 1104-4-25-M | Inquiry Steerable Curves | 4 | 4F | 2-5-2 mm | Med 3.2 cm | | 81541 | 1104-4-2-M | Inquiry Steerable Curves | 4 | 4F | 2 mm | Med 3.2 cm | | 81542 | 1104-4-5-M | Inquiry Steerable Curves | 4 | 4F | 5 mm | Med 3.2 cm | | 81543 | 1104-4-25-L | Inquiry Steerable Curves | 4 | 4F | 2-5-2 mm | Large 4.1 cm | | 81545 | 1104-4-5-L | Inquiry Steerable Curves | 4 | 4F | 5 mm | Large 4.1 cm | | 81587 | 1120-7-1(2.5)-SM-AF20 | A-Focus II Steerable Atrial | 20 | 7F | 1(2.5) mm | 20 mm diameter | | 81589 | 1114-7-15-SM-AF20 | A-Focus II Steerable Atrial | 14 | 7F | 1-5-1 mm | 20 mm diameter | | 81591 | 1114-7-13-SM-AF15 | A-Focus II Steerable Atrial | 14 | 7F | 1-3 mm | 15 mm diameter | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 81594 | 1110-7-3.5-SM-AF15 | A-Focus II Steerable Atrial | 10 | 7F | 3.5 mm | 15 mm diameter | | 81595 | 1110-7-5-SM-AF | A-Focus II Steerable Atrial | 10 | 7F | 5 mm | 20 mm diameter | | 81596 | 1110-7-27-SM-AF20 | A-Focus II Steerable Atrial | 10 | 7F | 2-7 mm | 20 mm diameter | | 81597 | 1110-7-2(11)-SM-AF25 | A-Focus II Steerable Atrial | 10 | 7F | 2(11) mm | 25 mm diameter | | 81598 | 1120-7-1(4.5)-SM-AF25 | A-Focus II Steerable Atrial | 20 | 7F | 1(4.5) mm | 25 mm diameter | | 81599 | 1110-7-8-SM-AF25 | A-Focus II Steerable Atrial | 10 | 7F | 8 mm | 25 mm diameter | | 81601 | 1106-6-5-M | Inquiry Steerable Curves | 6 | 6F | 5 mm | Med 3.2 cm | | 81602 | 1106-6-5-L | Inquiry Steerable Curves | 6 | 6F | 5 mm | Large 4.1 cm | | 81603 | 1106-6-5-E | Inquiry Steerable Curves | 6 | 6F | 5 mm | Extended Reach | | 81604 | 1106-6-5-F | Inquiry Steerable Curves | 6 | 6F | 5 mm | Far Reach | | 81605 | 1106-6-5-XL | Inquiry Steerable Curves | 6 | 6F | 5 mm | X-Large 5.0 cm | | 81670 | 1112-5-2-(10)-AF20 | A-Focus I Steerable Atrial | 12 | 5F | 2(10) mm | 25 mm diameter | | 81671 | 1114-5-2(9)-AF30 | A-Focus I Steerable Atrial | 14 | 5F | 2(9) mm | 30 mm diameter | | 81672 | 1110-5-27-SM-AF20 | A-Focus II Steerable Atrial | 10 | 5F | 2-7 mm | 20 mm diameter | | 81673 | 1110-5-5-SM-AF20 | A-Focus II Steerable Atrial | 10 | 5F | 5 mm | 20 mm diameter | | 81674 | 1110-5-5-AF20 | A-Focus I Steerable Atrial | 10 | 5F | 5 mm | 20 mm diameter | | 81676 | 1110-5-3.5-AF15 | A-Focus I Steerable Atrial | 10 | 5F | 3.5 mm | 15 mm diameter | | 81680 | 1110-5-3.5-SM-AF15 | A-Focus II Steerable Atrial | 10 | 5F | 3.5 mm | 15 mm diameter | | 81683 | 1120-7-1(4.5)-SM-OPT25 | Optima Steerable Lasso | 20 | 5F | 1(4.5) mm | 25 mm - 15 mm | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 81687 | 1110-7-10-SM-OPT25 | Optima Steerable Lasso | 10 | 7F | 10mm | 25 mm - 15 mm | | 81703 | 1110-5-28- M/L(SC)(XS)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-8-2 mm | Med 3.2 cm/ Large 4.1 cm | | 81704 | 1110-5-5- M/L(SC)(XS)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 5 mm | Med 3.2 cm/ Large SC 4.1 cm | | 81705 | 1110-5-28- M(SC)(XS)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-8-2 mm | M(SC)(XS) | | 81706 | 1110-5-5- M/L(XS)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 5 mm | M/L(XS) | | 81711 | 1108-5-5(20)5- E(HIS)(SOFT) | Inquiry HIS Steerable Curve | 8 | 5F | 5(20)5 mm | Extended | | 81717 | 1124-7-1(4.5)(20)(3)- SM-OPT25 | Optima Steerable Lasso | 24 | 7F | 4(4.5) | 25 mm - 15 mm | | 81721 | 1110-5-25- M(SC)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-5-2 mm | Med (SC) 3.2 cm | | 81730 | 1110-5-28-M/L(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-8-2 mm | M/L | | 81732 | 1110-5-25-M(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-5-2 mm | Med 3.2 cm | | 81733 | 1110-5-2-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2 mm | Large 4.1 cm | | 81734 | 1110-5-25-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-5-2 mm | Large 4.1 cm | | 81735 | 1110-5-5-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 5 mm | Large 4.1 cm | | 81738 | 1110-5-1-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 1 mm | Large 4.1 cm | | 81742 | 1104-5-25-M(SOFT) | Inquiry Soft Tip Steerable | 4 | 5F | 2-5-2 mm | Med 3.2 cm | | 81743 | 1104-5-5-M(SOFT) | Inquiry Soft Tip Steerable | 4 | 5F | 5 mm | Med 3.2 cm | | 81745 | 1104-5-25-L(SOFT) | Inquiry Soft Tip Steerable | 4 | 5F | 2-5-2 mm | Large 4.1 cm | | 81750 | 1110-5-25- L(60cm)(SOFT) | Inquiry Soft Tip Steerable | 10 | 5F | 2-5-2 mm | Large 4.1 cm | | 81751 | 1108-5-2-M(SOFT) | Inquiry Soft Tip Steerable | 8 | 5F | 2 mm | Med 3.2 cm | | 81801 | 1108-6-2-M | Inquiry Steerable Curves | 8 | 6F | 2 mm | Med 3.2 cm | | 81802 | 1108-6-25-M | Inquiry Steerable Curves | 8 | 6F | 2-5-2 mm | Med 3.2 cm | | 81807 | 1108-6-2-L | Inquiry Steerable Curves | 8 | 6F | 2 mm | Large 4.1 cm | | 81809 | 1108-6-25-L | Inquiry Steerable Curves | 8 | 6F | 2-5-2 mm | Large 4.1 cm | | 81823 | 1108-6-2-M(SOFT) | Inquiry Soft Tip Steerable | 8 | 6F | 2 mm | Med 3.2 cm | | 81871 | 1108-5-2-M | Inquiry Steerable Curves | 8 | 5F | 2 mm | Med 3.2 cm | | 81872 | 1108-5-25-M | Inquiry Steerable Curves | 8 | 5F | 2-5-2 mm | Med 3.2 cm | | 81873 | 1108-5-5-M | Inquiry Steerable Curves | 8 | 5F | 5 mm | Med 3.2 cm | | 81877 | 1108-5-2-L | Inquiry Steerable Curves | 8 | 5F | 2 mm | Large 4.1 cm | | 81879 | 1108-5-25-L | Inquiry Steerable Curves | 8 | 5F | 2-5-2 mm | Large 4.1 cm | | Item No. | Description | Trade Name | Electrodes | French Size | Electrode Spacing | Curve Type | | 81901 | 1120-7-13-M | Ten-Ten Duodecapolar | 20 | 7F | 1-3 mm | Medium 3.2 cm | | 81902 | 1120-7-13-L | Ten-Ten Duodecapolar | 20 | 7F | 1-3 mm | Large 4.2 cm | | 81940 | 1110-6-2-M(SOFT) | Inquiry Soft Tip Steerable | 10 | 6F | 2 mm | Med 3.2 cm | | 81943 | 1110-6-2-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 6F | 2 mm | Large 4.1 cm | | 81945 | 1110-6-25-L(SOFT) | Inquiry Soft Tip Steerable | 10 | 6F | 2-5-2 mm | Large 4.1 cm | | 81947 | 1110-6-5-M/L(SOFT) | Inquiry Soft Tip Steerable | 10 | 6F | 5 mm | M/L | | 81951 | 1104-6-5-M(SOFT) | Inquiry Soft Tip Steerable | 4 | 6F | 5 mm | Med 3.2 cm | | 81954 | 1104-6-5-L(SOFT) | Inquiry Soft Tip Steerable | 4 | 6F | 5 mm | Large 4.1 cm | | 85931 | 1924-S | Inquiry Diagnostic Connecting Cables | n/a | n/a | 1.5m length | n/a | | 85953 | 1910-SA | Inquiry Diagnostic Connecting Cables | n/a | n/a | 1.5m length | n/a | | 85954 | 1904-SA | Inquiry Diagnostic Connecting Cables | n/a | n/a | 1.5m length | n/a | | 85955 | 1914-SA | Inquiry Diagnostic Connecting Cables | n/a | n/a | 1.5m length | n/a | | 85930 | 1910-S | Inquiry Diagnostic Connecting Cables | n/a | n/a | 2.5m length | n/a | . {5}------------------------------------------------ : {6}------------------------------------------------ · {7}------------------------------------------------ ## Page 6 -- Ms. Katie Bray {8}------------------------------------------------ ## Page 7 – Ms. Katie Bray {9}------------------------------------------------ # Page 8 – Ms. Katic Bray : : {10}------------------------------------------------ Page 9 -- Ms. Katie Bray {11}------------------------------------------------ : : Page 10 ·· Ms. Katie Bray . {12}------------------------------------------------ ## SECTION 4: INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: Reprocessed Electrophysiology Catheters Indications For Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) eamall Division of Cardiovascular Devices Kos1329 510(k) Number > Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)