← Product Code [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) · K021591 # PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K021591) _Cordis Neurovascular, Inc. · KRA · May 22, 2002 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K021591 ## Device Facts - **Applicant:** Cordis Neurovascular, Inc. - **Product Code:** [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA.md) - **Decision Date:** May 22, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures. ## Device Story Single-lumen infusion catheter; stiff proximal shaft; flexible distal section; radiopaque body with distal markers; hydrophilic outer coating; PTFE inner liner. Used by physicians in neuro, peripheral, or coronary vascular procedures. Functions as conduit for infusion of diagnostic, embolic, or therapeutic agents; provides guidewire support/exchange; enables superselective angiography. Output is delivery of agents or visualization via angiography. Benefits patient by facilitating targeted vascular access and therapy. ## Clinical Evidence Bench testing only. Verification testing included outer diameter inspection, visual inspection, flexible coil/distal zone length inspection, lateral stiffness, trackability, joint pull test, and static burst testing. All materials confirmed biocompatible. ## Technological Characteristics Single-lumen catheter; materials include PTFE liner and hydrophilic coating; radiopaque distal markers. Dimensions accommodate 0.014" (10/14 models) or 0.018" (PLUS model) guidewires. Mechanical device; no energy source or software. ## Regulatory Identification A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping. ## Predicate Devices - PROWLER® Infusion Catheters ([K965181](/device/K965181.md), [K972518](/device/K972518.md)) - PROWLER® PLUS Infusion Catheters ([K993266](/device/K993266.md)) - PROWLER® Infusion Catheters with pre-shaped tips ([K003925](/device/K003925.md)) - PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips ([K020680](/device/K020680.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## MAY 2 2 2002 ## Attachment 4 . 12 11 # 0-000025 # Summary of Safety and Effectiveness | Submitter's
Name/Contact
Person | The submitter of this special 510(k) is:

Cordis Neurovascular, Inc.
14000 N.W. 57th Court
Miami Lakes, Florida 33014

Establishment Registration No. 1058196

Contact: Maritza Celaya
Sr. Regulatory Affairs Associate

Tel: (786) 313-6546
Fax: (786) 313-6480

May 14, 2002 | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name /
Common Name | Trade Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and
without pre-shaped tips

Common/Classification Name: Catheters, Continuous Flush | | Classification | Class II | | Performance
Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established
performance standards. | | Intended Use and
Device
Description | The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-
shaped tips are intended to be used as a mechanism for the infusion of various diagnostic,
embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for
Guidewire Exchange/Support, and for superselective angiography of the peripheral and
coronary vasculatures. | | Device
Description | The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-
shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal
section. The catheter's inner diameter accommodates guidewires of .018" and smaller for
PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10
and 14, depending on the catheter type. The catheter body is radiopaque with one or two
distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of
the shaft as well as a PTFE liner on the inner lumen. | Continued on next page {1}------------------------------------------------ ## Summary of Safety and Effectiveness, Continued 0-000026 | Device | Company | 510 (k) Number | Product Code | |------------------------------------------------------------------------------------------|-------------------------------|--------------------|--------------| | PROWLER® Infusion
Catheters | Cordis Neurovascular,
Inc. | K965181
K972518 | 74KRA | | PROWLER® PLUS
Infusion Catheters | Cordis Neurovascular,
Inc. | K993266 | 74KRA | | PROWLER® Infusion
Catheters with pre-shaped
tips | Cordis Neurovascular,
Inc. | K003925 | 74KRA | | PROWLER® SELECTTM
10 and 14 Infusion
Catheters with and without
pre-shaped tips | Cordis Neurovascular,
Inc. | K020680 / 3/27/02 | 74KRA | The predicate devices are listed in the table below: Predicate Devices #### Summary of Studies Design verification testing demonstrated that the PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips performed as intended. No new questions of safety and effectiveness were raised. Design verification testing included: - . Outer Diameter Dimension Inspection (pre-coating) - . Visual Inspection - Flexible Coil Length Inspection/Distal Zone Length Inspection ● - . Lateral Stiffness - . Trackability - Joint Pull Test . - Static Burst Testing . All materials used in the PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are biocompatible. Summary of Substantial Equivalence The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without preshaped tips are substantially equivalent to the predicate devices. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### MAY 2 2 2002 Ms. Maritza Celaya Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014 Re: K021591 PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips Regulation Number: 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: 74 KRA Dated: May 14, 2002 Received: May 15, 2002 Dear Ms. Celaya: 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. 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 {3}------------------------------------------------ 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, N. Deetun Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Cordis Franchise Form -- CFF 20-014 Rev.01 Intended Use Statement Page I of Effective Date: 11/15/00 Cordis a fohnson-fohnson company Page 1 of 1 ### 510(k) Number (if known): Ko2159 | Device Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters (with and without pre-shaped tips) #### Indications for Use Statement The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ✓ Over-The-Counter Use Division of Cardiovascular & Respiratory Devices 510(k) Number K021597 OR Prescription Use √ --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K021591](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K021591) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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