PROWLER PLUS INFUSION CATHETER

K993266 · Cordis Neurovascular, Inc. · KRA · Oct 28, 1999 · Cardiovascular

Device Facts

• Record ID: K993266
• Device Name: PROWLER PLUS INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Oct 28, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Prowler 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

Prowler Plus Infusion Catheter is a single-lumen catheter designed for vascular access. Device features stiff proximal shaft and flexible distal section; radiopaque marker at distal tip for visualization. Outer shaft includes hydrophilic coating; inner lumen features PTFE liner. Catheter accommodates guidewires up to .018". Used by clinicians in neuro, peripheral, and coronary vascular procedures to deliver diagnostic, embolic, or therapeutic agents, provide guidewire support, or perform superselective angiography. Device facilitates targeted delivery of agents to specific vascular sites, potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. Design verification testing included pull strength, trackability, dimensional testing, static burst pressure, flow rate calculation, air aspiration, linear stiffness (boink), and shapeability tests. No clinical data provided.

Technological Characteristics

Single-lumen catheter; stiff proximal shaft, flexible distal section. Materials include radiopaque marker at distal tip, hydrophilic coating on outer shaft, and PTFE liner on inner lumen. Accommodates guidewires up to .018".

Indications for Use

Indicated for patients requiring infusion of diagnostic, embolic, or therapeutic agents into neuro, peripheral, or coronary vascular systems, guidewire exchange/support, or superselective angiography of peripheral and coronary vasculatures.

Regulatory Classification

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 Catheter
• Rapid Transit Infusion Catheter

Submission Summary (Full Text)

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## Attachment 4

## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Prowler Plus Infusion Catheter<br>Common/Classification Name: Infusion Catheter |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Cordis Endovascular Systems, Inc. Prowler Infusion Catheter, and Rapid<br>Transit Infusion Catheter. |
| Classification | Class II |
| Performance<br>Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established<br>performance standards. |
| Intended Use<br>and Device<br>Description | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the<br>infusion of various diagnostic, embolic, and therapeutic agents into the vascular<br>systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for<br>superselective angiography of the peripheral and coronary vasculatures.<br><br>The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and a<br>flexible distal section. The catheter's inner diameter accommodates guidewires of |
| Summary of<br>Studies | .018" and smaller. The catheter body is radiopaque with a distinguishable marker at<br>the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a<br>PTFE liner on the inner lumen.<br><br>Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or<br>better than the predicate devices tested. No new questions of safety and effectiveness were<br>raised. Design verification testing included:<br>• Pull Strength Test<br>• Trackability Test<br>• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)<br>• Static Burst Pressure Test<br>• Alternative Flow Rate Calculation<br>• Air Aspiration<br>• Linear Stiffness Test (Boink)<br>• Shapeability Test |
| Biocompatibility | All materials used in the Prowler Plus Infusion Catheters are biocompatible. |
| Summary of<br>Substantial<br>Equivalence | The Prowler Plus Infusion Catheters are substantially equivalent to the previously<br>cleared Prowler and Rapid Transit Infusion Catheters. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 1999

Ms. Maritza Celaya Sr. Regulatory Affairs Specialist Cordis Endovascular SystemS, Inc. p.o. Box 025700 Ct. Miami Lakes, FL 33102-5700

Re: K993266 K993266
Trade Name: Prowler Plus Infusion Catheter Regulatory Class: II Product Code: KRA Dated: September 29, 1999 September 30, 1999 Received:

Dear Ms. Celaya:

We have reviewed your Section 510(k) notification of intent to market the f
actived by the becale boys determined the device is We have reviewed your securer state determined the device is device referenced above and we nave associons for use stated in the substantially equivalent (10) the indites marketed in interstate enclosure) to legally marketed breatment date of the Medical Device commerce prior to May 28, 1976, the encements assisted in accordance with Amendments, or to devices that nave been, and Cosmetic Act (Act). You
the provisions of the Federal Food, Drug, and Cosmeral controls the provisions of the rederal rood, bray and the general controls
may, therefore, market the device, subject to the Act may, therefore, market the device, busferols provisions of the Act
provisions of the Act. The general controls provisions of provisions of the Act. The general concross productions of devices, good
include requirements for annual registration, against misbranding include requirements for annual registration, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is classified (see aboro), it may be subject to such Controls) or class III (reliminer regions affecting your device additional controls. Extrema Requires Title 21, Parts 800 to
can be found in the Code of Federal Requires compliance with e found in the Code of rederal Requirement compliance with 895. 895. A substantially equivalence active requirements, as set forth in the Current General regulation the Current Good Manufacturing Frassis al Devices: General regulation Quality System Regulation (QS) Lockidations inspections, the Food and (21 CFR Part 820) and that, through percula assumptions . Failure to comply
Drug Administration (FDA) will verify such assumptions. In addition, Drug Administration (FDA) will versily bagulatory action. In addition,
with the GMP regulation may result in regulation your device in the with the GMP regulation may rebare in concerning your device in the
FDA may publish further announcements concern to your premarket FDA may publish further announces to your premarket.
Federal Register. Please note: this response thirstion you might rederal Rediscer. Prease noce. Enterespection you might have
notification submission does not affect any for douices notification basmissions of the Act for devices

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Paye 2 - Ms. Maritza Celaya

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in This fecter will arrow you oo begin to the FDA finding of substantial your 510(k) prematics. I legally marketed prodicate device results
equivalence of your device to a legally marketed with mown device to equivalence of your device to a regulary
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 in II you desire speciele additionally 809.10 for in vitro diagnostic (21 CFR Part over and addressions)
devices), please contact the Office of Compliance at [phone]. devices), prease concacions on the promotion and advertising of your Additionally, for questions on the primeses [phone]. Also, as a regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premarket nocification (arch over may be obtained from the Division of your responsibilities under ens tool -----------------------------------------------------------------------------------------------------------------------------------------[phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

At. A. LiachowsL.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2

| 510(k) Number<br>(if known) | The 510(k) number has not yet been assigned. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Prowler Plus Infusion Catheters. |
| Indications for<br>Use | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the<br>infusion of various diagnostic, embolic, and therapeutic agents into the vascular<br>systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for<br>superselective angiography of the peripheral and coronary vasculatures. |

## Indications for Use Statement

PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher Witten.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993266

× Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use