Who is the manufacturer of REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS?

Sterilmed, Inc. filed the 510(k) submission for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K101789).

What is the FDA product code for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC 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 DIAGNOSTIC CATHETERS?

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

What are the predicate devices for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS?

Irvine Biomedical, Inc. catheters (K060757, K053582, K042775, K010471, K990958, K982232, K961924, K946333).

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

K101789 · Sterilmed, Inc. · NLH · Aug 19, 2010 · Cardiovascular

Device Facts

Record ID	K101789
Device Name	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Applicant	Sterilmed, Inc.
Product Code	NLH · Cardiovascular
Decision Date	Aug 19, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Device Story

Reprocessed electrophysiology (EP) diagnostic catheters; consist of shaft with proximal handle; some models steerable. Feature platinum, radiopaque electrodes with varying spacing and curve styles at distal tip. Cables connect handle to external stimulator/electrophysiological recorder. Used in clinical electrophysiology studies; operated by physicians. Device inputs are cardiac electrical signals; outputs are electrical signals transmitted to external recording/stimulation equipment. Facilitates mapping and evaluation of cardiac structures and arrhythmias; aids clinical decision-making regarding cardiac rhythm management. Benefits patient through diagnostic assessment of cardiac electrical activity.

Clinical Evidence

Bench testing only. Testing included cleaning validation, sterilization validation (ISO 11135, USP <71>), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging validation (ASTM D4169, F88, F1929, F2096), and shelf life (ASTM 1980-99). Functional bench testing included electrical leakage, torsional strength, flexation fatigue, fluid integrity, joint bond strength, deflection fatigue, catheter stiffness, and tip buckling.

Technological Characteristics

Catheter shaft with proximal handle; platinum, radiopaque electrodes. Materials and construction methods identical to predicate. Connectivity via cables to external stimulator/recorder. Sterilization via ethylene oxide. No software or algorithm components.

Indications for Use

Indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

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

Irvine Biomedical, Inc. catheters (K060757, K053582, K042775, K010471, K990958, K982232, K961924, K946333)

Related Devices

K092158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS · Sterilmed, Inc. · Jan 14, 2010
K112232 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS · Stryker Sustainability Solutions · Sep 26, 2011
K051220 — REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS · Sterilmed, Inc. · Jun 14, 2005
K171503 — Reprocessed CristaCath Diagnostic Electrophysiology Catheter · Innovative Health, LLC · Oct 5, 2017
K180710 — Reprocessed DecaNav Diagnostic Electrophysiology Catheter · Innovative Health, LLC · Jun 19, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 10/789 ### I. SUMMARY AND CERTIFICATION AUG 1 9 2010 | A. | 510(k) Summary | | | | | | |----|------------------------|--------------------------------------------------------------------------------------------------------------|--|--|--|--| | | Submitter: | SterilMed, Inc. | | | | | | | Contact Person: | Garrett Ahlborg 11400 73rd Avenue North Maple Grove, MN 55369 Ph: 763-488-3483 Fax: 763-488-2051 | | | | | | | Date Prepared: | June 25, 2010 | | | | | | | Trade Name: | Reprocessed Electrophysiology Diagnostic Catheters | | | | | | | Classification Name: | Electrode Recording Catheter or Electrode Recording Probe | | | | | | | Classification Number: | Class II, 21 CFR 870.1220 | | | | | | | Product Code: | NLH | | | | | | Predicate Devices: | The reprocessed EP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (510(k)'s K060757, K053582, K042775, K010471, K990958, K982232, K961924, and K946333). | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description: | SterilMed Reprocessed Irvine Biomedical EP diagnostic catheters consist of a shaft with a handle at the proximal end and some models are considered to be steerable. These catheters have a varying outer diameter (French size) and length. These catheters also feature a number of platinum, radiopaque electrodes with a variety of inter-electrode spacing configurations and curve styles at the distal tip. The distal tip may be steerable and cables connect to the handle and interface between the catheter and an external stimulator and /or an electrophysiological recorder. Note: Only the catheter is the subject of this submission, the external stimulator and /or electrophysiological recorder and any other related equipment are not included in the scope of this submission. | | Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. | | Functional and Safety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced. | | Summary of Non- clinical Tests Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP <71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-99). In addition, validation of functional performance (bench testing) was performed and included the following tests: electrical leakage, torsional strength, flexation fatigue, fluid integrity, joint bond strength, deflection fatigue, catheter stiffness, and tip buckling. | | Conclusion: | The reprocessed EP diagnostic catheters are substantially equivalent to the Irvine Biomedical, Inc. electrophysiology diagnostic catheters. This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SterilMed, Inc. c/o Mr. Garret Ahlborg Regulatory Affairs Manager 11400 73td Avenue North Maple Grove, MN 55369 AUG 1 9 2010 Re: K101789 > Trade/Device Name: Reprocessed EP Diagnostic Catheter (See Enclosed List) Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: II (two) Product Code: 74 NLH Dated: June 25, 2010 Received: June 28, 2010 Dear Mr. Ahlborg: 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 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. {2}------------------------------------------------ Page 2 - Mr. Garret Ahlborg Please be advised that FDA's issuance of a substantial equivalence 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Page 3 – Mr. Garret Ahlborg ## LIST OF DEVICE MODELS COVERED BY THIS SUBMISSION: :. | Item | Description | Trade Name | Electrodes | French | Electrode Spacing | Curve Type | |-------|-----------------------------------|--------------------------------------|------------|--------|---------------------|-----------------------| | 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 | | 81591 | 1114-7-13-SM-AF15 | A-Focus II Steerable Atrial | 14 | 7F | 1-3mm | 15 mm | | 81594 | 1110-7-3.5-SM-AF15 | A-Focus II Steerable Atrial | 10 | 7F | 3.5mm | 15 mm | | 81595 | 1110-7-5-SM-AF | A-Focus II Steerable Atrial | 10 | 7F | 5 mm | 20 mm | | 81596 | 1110-7-27-SM-AF20 | A-Focus II Steerable Atrial | 10 | 7F | 2-7mm | 20 mm | | 81597 | 1110-7-2(11)-SM-AF25 | A-Focus II Steerable Atrial | 10 | 7F | 2(11) mm | 25 mm | | 81598 | 1120-7-1(4.5)-SM-AF25 | A-Focus II Steerable Atrial | 20 | 7F | 1(4.5) mm | 25 mm | | 81599 | 1110-7-8-SM-AF25 | A-Focus II Steerable Atrial | 10 | 7F | 8mm | 25 mm | | 81670 | 1112-5-2-(10)-AF20 | A-Focus II Steerable Atrial | 12 | 5F | 2(10) mm | 25 mm | | 81671 | 1114-5-2(9)-AF30 | A-Focus II Steerable Atrial | 14 | 5F | 2(9) mm | 30 mm | | 81672 | 1110-5-27-SM-AF20 | A-Focus II Steerable Atrial | 10 | 5F | 2-7 mm | 20 mm | | 81673 | 1110-5-5-SM-AF20 | A-Focus II Steerable Atrial | 10 | 5F | 5mm | 20 mm | | 81674 | 1110-5-5S-AF20 | A-Focus II Steerable Atrial | 10 | 5F | 5mm | 20 mm | | 81676 | 1110-5-3.5-AF15 | A-Focus II Steerable Atrial | 10 | 5F | 3.5mm | 15 mm | | 81680 | 1110-5-3.5-SM-AF15 | A-Focus II Steerable Atrial | 10 | 5F | 3.5mm | 15 mm | | 81503 | 1104-6-5-L-TE2BE2-BD | Inquiry Bi-Directional | 4 | 6F | 5mm | Large 4.1 cm | | 81504 | 1110-6-5-M-TE2BE2-BD | Inquiry Bi-Directional | 10 | 6F | 5mm | Med 3.2 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-SA | Inquiry Diagnostic Connecting Cables | n/a | n/a | 2.5m length | n/a | | 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 | Coumand | | 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 | 2MM | 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 | Coumand | | 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 | 5mm | 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 | | 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 | 10mm | Josephson | | 80414 | 1004-6-10-C | Inquiry Fixed Curve | 4 | 6F | 10mm | Cournand | | 80415 | 1004-6-10-D | Inquiry Fixed Curve | 4 | 6F | 10mm | Domato | | 80451 | 1004-5-2-J | Inquiry Fixed Curve | 4 | 5F | 2mm | 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 | 5mm | 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 | 5mm | Cournand | | 80458 | 1004-5-25-C | Inquiry Fixed Curve | 4 | 5F | 2-5-2 mm | Domato | | 80459 | 1004-5-5-D | Inquiry Fixed Curve | 4 | 5F | 5mm | Domato | | 80463 | 1004-5-10-C | Inquiry Fixed Curve | 4 | 5F | 10mm | Cournand | | 80464 | 1004-4-2-C | Inquiry Fixed Curve | 4 | 4F | 2mm | Cournand | | 80465 | 1004-4-5-C | Inquiry Fixed Curve | 4 | 4F | 5mm | Cournand | | 80466 | 1004-4-25-C | Inquiry Fixed Curve | 4 | 4F | 2-5-2mm | Cournand | | 80467 | 1004-4-2-J | Inquiry Fixed Curve | 4 | 4F | 2mm | Josephson | | 80468 | 1004-4-5-J | Inquiry Fixed Curve | 4 | 4F | 5mm | Josephson | | 80469 | 1004-4-25-J | Inquiry Fixed Curve | 4 | 4F | 2-5-2mm | Josephson | | 80484 | 1004-5-5-J1 | Inquiry Fixed Curve | 4 | 5F | 5mm | Josephson I | | 80485 | 1004-4-5-JI | Inquiry Fixed Curve | 4 | 4F | 5mm | Josephson 1 | | 80501 | 1005-6-25-C | Inquiry Fixed Curve | 5 | 6F | 2-5-2mm | Cournand | | 80508 | 1005-6-25-J | Inquiry Fixed Curve | 5 | 6F | 2-5-2mm | Josephson | | 80535 | 1004-4-25-JI | Inquiry Fixed Curve | 4 | 4F | 2-5-2mm | Josephson I | | 80536 | 1004-4-5-D | Inquiry Fixed Curve | 4 | 4F | 5mm | Domato | | 80602 | 1006-6-25-J | Inquiry Fixed Curve | 6 | 6F | 2-5-2mm | Josephson | | 80603 | 1006-6-5-J | Inquiry Fixed Curve | 6 | 6F | 5mm | Josephson | | 80604 | 1006-6-2-C | Inquiry Fixed Curve | 6 | 6F | 2mm | Cournand | | 80606 | 1006-6-5-C | Inquiry Fixed Curve | 6 | 6F | 5mm | Cournand | | 80803 | 1008-6-5-J | Inquiry Fixed Curve | 8 | 5F | 5mm | Josephson | | 80804 | 1008-6-2-C | Inquiry Fixed Curve | 8 | 6F | 2mm | Cournand | | 80806 | 1008-6-5-D | Inquiry Fixed Curve | 8 | 6F | 5mm | Damato | | 80810 | 1008-6-5-C | Inquiry Fixed Curve | 8 | 6F | 5mm | Cournand | | 80900 | 1014-7-3(70)-TE2BE2 | Inquiry Fixed Curve | 14 | 7F | 3-3-3-3-3-3-70 | Cournand | | 81110 | 1110-6-17-H | Inquiry H Steerable Atrial | 10 | 6F | 1 & 7mm | H | | 81120 | 1120-7-17-H | Inquiry H Steerable Atrial | 20 | 7F | 1 & 7mm | H | | 81121 | 1121-7-17-H-SC | Inquiry H Steerable Atrial | 21 | 7F | 1-7-1mm | H-SC | | 81124 | 1124-7-271-H | Inquiry H Steerable Atrial | 24 | 7F | 2-7-1mm | H | | 81125 | 1106-6-27-H | Inquiry H Steerable Atrial | 6 | 6F | 2-7-2mm | H | | 81126 | 1110-6-291-HL | Inquiry H Steerable Atrial | 10 | 6F | 2-9-1mm | HL | | 81128 | 1121-7-5-H-UP | Inquiry H Steerable Atrial | 21 | 7F | 5mm | H | | 81130 | 1120-7-19-HL | Inquiry H Steerable Atrial | 20 | 7F | 1 & 9mm | HL | | 81131 | 1121-7-19-HL-SC | Inquiry H Steerable Atrial | 21 | 7F | 1-9-1mm | HL-SC | | 81134 | 1124-7-291-HL | Inquiry H Steerable Atrial | 24 | 7F | 2-9-1mm | HL | | 81136 | 1120-7-5-HL-UP | Inquiry H Steerable Atrial | 20 | 7F | 5mm | HL | | 81142 | 1106-6-27-HL | Inquiry H Steerable Atrial | 6 | 6F | 2-7-2mm | HL | | 81150 | 1124-7-271-H-SCE | Inquiry H Steerable Atrial | 24 | 7F | 2-7-1mm | H-SCE | | 80567 | 1004-4-5-C(HIS) | Inquiry HIS Fixed | 4 | 4F | 5mm | Cournand | | 80820 | 1008-5-5-(20)5-C(HIS) | Inquiry HIS Fixed | 8 | 5F | 20(5)mm | Cournand | | 81101 | 1110-6-2-F | Inquiry Steerable Curves | 10 | 6F | 2mm | Med 3.2 cm | | 81102 | 1110-6-25-M | Inquiry Steerable Curves | 10 | 6F | 2-5-2mm | Med 3.2 cm | | 81104 | 1110-6-25-L | Inquiry Steerable Curves | 10 | 6F | 2-5-2mm | Large 4.1 cm | | 81105 | 1110-6-25-XL | Inquiry Steerable Curves | 10 | 6F | 2-5-2mm | X-Large 5.0cm | | 81106 | 1110-6-25-F | Inquiry Steerable Curves | 10 | 6F | 2-5-2mm | Far Reach | | 81107 | 1110-6-5-L | Inquiry Steerable Curves | 10 | 6F | 5mm | Large | | 81108 | 1110-6-2-L | Inquiry Steerable Curves | 10 | 6F | 2mm | Large | | 81109 | 1110-6-2-L-TE2BE2 | Inquiry Steerable Curves | 10 | 6F | 2mm | Large | | 81171 | 1110-5-2-M | Inquiry Steerable Curves | 10 | 5F | 2mm | Med 3.2 cm | | 81172 | 1110-5-25-M | Inquiry Steerable Curves | 10 | 5F | 2-5-2mm | Med 3.2 cm | | 81174 | 1110-5-25-L | Inquiry Steerable Curves | 10 | 5F | 2-5-2mm | Large 4.1 cm | | 81176 | 1110-5-25-L | Inquiry Steerable Curves | 10 | 5F | 2-5-2mm | Far Reach | | 81177 | 1110-5-5-L | Inquiry Steerable Curves | 10 | 5F | 5mm | Large 4.1 cm | | 81178 | 1110-5-2-L | Inquiry Steerable Curves | 10 | 5F | 2mm | Large 4.1 cm | | 81179 | 1110-5-2-E | Inquiry Steerable Curves | 10 | 5F | 2mm | Extended Reach | | 81223 | 1110-5-2(20)3-XL | Inquiry Steerable Curves | 10 | 5F | 2(50)3mm | 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 | 2-5-2mm | Medium 3.2 | | 81403 | 1104-6-5-M | Inquiry Steerable Curves | 4 | 6F | 5mm | Medium 3.2 | | 81404 | 1104-6-25-L | Inquiry Steerable Curves | 4 | 6F | 2-5-2mm | Large 4.2 cm | | 81405 | 1104-6-5-L | Inquiry Steerable Curves | 4 | 6F | 5mm | Large 4.2 cm | | 81406 | 1104-6-25-E | Inquiry Steerable Curves | 4 | 6F | 2-5-2mm | Extended Reach | | 81407 | 1104-6-25-F | Inquiry Steerable Curves | 4 | 6F | 2-5-2mm | Far Reach Extended | | 81412 | 1104-6-2-E | Inquiry Steerable Curves | 4 | 6F | 2mm | Extended Reach | | 81417 | 1104-6-5-XL | Inquiry Steerable Curves | 4 | 6F | 5mm | X-Large 5.0 | | 81418 | 1104-6-25-XL | Inquiry Steerable Curves | 4 | 6F | 2-5-2mm | X-Large 5.0 | | 81471 | 1104-5-5-S | Inquiry Steerable Curves | 4 | 5F | 5mm | Small 2.7 cm | | 81472 | 1104-5-25-M | Inquiry Steerable Curves | 4 | 5F | 2-5-2mm | Med 3.2 cm | | 81473 | 1104-5-5-M | Inquiry Steerable Curves | 4 | 5F | 5mm | Med 3.2 cm | | 81474 | 1104-5-25-L | Inquiry Steerable Curves | 4 | 5F | 2-5-2mm | Large 4.1 cm | | 81475 | 1104-5-5-L | Inquiry Steerable Curves | 4 | 5F | 5mm | Large 4.1 cm | | 81479 | 1104-5-25-S | Inquiry Steerable Curves | 4 | 5F | 2-5-2mm | Small 2.7 cm | | 81511 | 1105-6-25-M | Inquiry Steerable Curves | 6 | 6F | 2-5-2mm | Med 3.2 cm | | 81520 | 1110-6-2-XL-TE4BE4 | Inquiry Steerable Curves | 10 | 6F | 2mm | X-Large 5.0 | | 81524 | 1110-6-2-L-TE4BE4 | Inquiry Steerable Curves | 10 | 6F | 2mm | Large 4.1 cm | | 81530 | 1110-4-2-M | Inquiry Steerable Curves | 10 | 4F | 2mm | Med 3.2 cm | | 81531 | 1110-4-25-M | Inquiry Steerable Curves | 10 | 4F | 2-5-2mm | Med 3.2 cm | | 81532 | 1110-4-025-L | Inquiry Steerable Curves | 10 | 4F | 2-5-2mm | Large 4.1 cm | | 81534 | 1110-4-5-L | Inquiry Steerable Curves | 10 | 4F | 5mm | Large 4.1 cm | | 81536 | 1110-4-25-M(80) | Inquiry Steerable Curves | 10 | 4F | 2-5-2mm | Med 3.2 cm | | 81537 | 1110-4-25-M(SC)(60) | Inquiry Steerable Curves | 10 | 4F | 2-5-2mm | Med 3.2 cm | | 81540 | 1104-4-25-M | Inquiry Steerable Curves | 4 | 4F | 2-5-2mm | Med 3.2 cm | | 81541 | 1104-4-2-M | Inquiry Steerable Curves | 4 | 4F | 2mm | Med 3.2 cm | | 81542 | 1104-4-5-M | Inquiry Steerable Curves | 4 | 4F | 5mm | Med 3.2 cm | | 81543 | 1104-4-25-L | Inquiry Steerable Curves | 4 | 4F | 2-5-2mm | Large 4.1 cm | | 81545 | 1104-4-5-L | Inquiry Steerable Curves | 4 | 4F | 5mm | Large 4.1 cm | | 81601 | 1106-6-5-M | Inquiry Steerable Curves | 6 | 6F | 5mm | Med 3.2 cm | | 81602 | 1106-6-5-L | Inquiry Steerable Curves | 6 | 6F | 5mm | Large 4.1 cm | | 81603 | 1106-6-5-E | Inquiry Steerable Curves | 6 | 6F | 5mm | Extended Reach | | 81604 | 1106-6-5-F | Inquiry Steerable Curves | 6 | 6F | 5mm | Far Reach | | 81605 | 1106-6-5-XL | Inquiry Steerable Curves | 6 | 6F | 5mm | X-Large 5.0 | | 81801 | 1108-6-2-M | Inquiry Steerable Curves | 8 | 6F | 2mm | 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 | 2mm | Large 4.1 cm | | 81809 | 1108-6-25-L | Inquiry Steerable Curves | 8 | 6F | 2-5-2 mm | Large 4.1 cm | | 81871 | 1108-5-2-M | Inquiry Steerable Curves | 8 | 5F | 2mm | 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 | 5mm | Med 3.2 cm | | 81877 | 1108-5-2-L | Inquiry Steerable Curves | 8 | 5F | 2mm | Large 4.1 cm | | 81879 | 1108-5-25-L | Inquiry Steerable Curves | 8 | 5F | 2-5-2 mm | Large 4.1 cm | | 81683 | 1120-7-1(4.5)-SM-OPT25 | Optima Steerable Lasso | 20 | 5F | 1(4.5)- 1(4.5)mm | 25-15mm | | 81659 | 1120-7-1(4.5)-SM-OPT25-EB | Optima Steerable Lasso | 20 | 7F | 1(4.5)- 1(4.5)mm | 25-15mm | | 81687 | 1110-7-10-SM-OPT25 | Optima Steerable Lasso | 10 | 7F | 10mm | 25-15mm | | 81717 | 1124-7-1(4.5)(20)(3)-SM- OPT25 | Optima Steerable Lasso | 24 | 7F | 4(4.5) | 25-15mm | | 81202 | 1120-7-2-10-XXL | Ten-Ten Duodecapolar | 20 | 7F | 2-10mm | XX Large 4.8 | | 81207 | 1120-7-5-SL | Ten-Ten Duodecapolar | 20 | 7F | 5mm | Super Lrg 5.1 | | 81209 | 1120-7-25-SL | Ten-Ten Duodecapolar | 20 | 7F | 2-5mm | Super Lrg 5.1 | | 81211 | 1120-7-2(20)2(25)2-SL | Ten-Ten Duodecapolar | 20 | 7F | 2(20)2(25)2mm | Super Lrg 5.1 | | 81901 | 1120-7-13-M | Ten-Ten Duodecapolar | 20 | 7F | 1-3mm | Med 3.2 cm | | 81902 | 1120-7-13-L | Ten-Ten Duodecapolar | 20 | 7F | 1-3mm | Large 4.2 cm | and the comments of the country of the country of . {4}------------------------------------------------ ### Page 4 – Mr. Garret Ahlborg A {5}------------------------------------------------ ### Page 5 -- Mr. Garret Ahlborg . . . . · ・ . 1.0 . {6}------------------------------------------------ ### Page 6 – Mr. Garret Ahlborg : : . . . and the control control control control controllers. : : : : {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for STERILMED, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair." **Indications for Use** 510(k) Number (if known): K101789 Image /page/7/Picture/4 description: The image contains a few black spots scattered across a white background. The spots are irregular in shape and size, with some appearing as small dots and others as larger, more elongated marks. The distribution of the spots is uneven, with some areas having a higher concentration than others. Device Name: Reprocessed Electrophysiology Diagnostic Catheters Indications for Use: The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) Division of Cardiovascular Devices | | | 510(k) Number | K101789 | Page 1 of 1 CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.