← Product Code [DSY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY) · K983861

# DISTAFLO BYPASS GRAFT (K983861)

_Impra, Inc. · DSY · Nov 24, 1998 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K983861

## Device Facts

- **Applicant:** Impra, Inc.
- **Product Code:** [DSY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY.md)
- **Decision Date:** Nov 24, 1998
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 870.3450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

## Device Story

Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft featuring a cuffed distal end; design modeled after Miller Vein Cuff. Device manufactured with or without Flex beading and with or without carbon lining. Intended for surgical bypass or reconstruction of peripheral arterial blood vessels. Implanted by vascular surgeons in clinical settings. Device provides a conduit for blood flow in peripheral arterial applications. Performance validated through bench testing comparing cuffed portion to predicate grafts.

## Clinical Evidence

Bench testing only. Testing performed on the cuffed portion of the Distaflo Bypass Graft compared to IMPRA Carboflo and Venaflo grafts using methods from ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance. Results demonstrated the device is suitable for peripheral arterial bypass/reconstruction and performs equivalently to predicate devices.

## Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) vascular graft; distal cuff design modeled after Miller Vein Cuff. Options include Flex beading and carbon lining. Testing performed per ANSI/AAMI VP20-1994 standards.

## Regulatory Identification

A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”

## Predicate Devices

- IMPRA Carboflo Vascular Graft
- Venaflo Vascular Graft (Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon)

## 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}------------------------------------------------

NOV 24 1998

K983861

impra

A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: 800-321-4254 602-894-9515 FAX: 602-966-7062

IMRA

CONFIDENTIAL

### 510(k) Premarket Notification DISTAFLOTM Bypass Graft

## 510(k) SUMMARY

#### Submitter Information A.

| Submitter's Name:    | IMPRA, Inc.<br>A Subsidiary of C. R. Bard, Inc.  |
|----------------------|--------------------------------------------------|
| Address:             | 1625 West Third Street<br>Tempe, Arizona 85281   |
| Telephone:           | (602) 894-9515                                   |
| Fax:                 | (602) 966-7062                                   |
| Contact Person:      | Kristi M. Kistner<br>Manager, Regulatory Affairs |
| Date of Preparation: | October 29, 1998                                 |

#### B. Device Name

| Trade Name:           | <i>Distaflo</i> ™ Bypass Graft                         |
|-----------------------|--------------------------------------------------------|
| Common/Usual Name:    | Vascular Graft Prosthesis                              |
| Classification Names: | Vascular graft prostheses of 6 mm and greater diameter |

IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\DistafloGT6.wpd**25**

000030

Image /page/0/Picture/13 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The image has a slightly distressed or textured appearance, as if it were printed on a rough surface. The letters are evenly spaced and aligned horizontally.

{1}------------------------------------------------

#### ز Predicate Device Name

Trade Name(s):

IMPRA Carboflo® Vascular Graft Venaflo® Vascular Graft (Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon)

#### D. Device Description

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

#### E. Intended Use

The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.

#### F. Technological Characteristics Summary

The Distaflo Bypass Graft is manufactured using the same materials and processes as the predicate devices. The shape of the distal cuff is modeled after the Miller Vein Cuff.

#### Performance Data (..

Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon. The testing was conducted using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. The results of all testing indicated that the Distaflo Bypass Graft is suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the Distaflo Bypass Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.

{2}------------------------------------------------

Distaflo Bypass Grafts are substantially equivalent to the currently marketed IMPRA

Carboflo Vascular Graft and the Venaflo Vascular Graft.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

# NOV 2 4 1998

Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85281-1740

K983861 Re: IMPRA Distaflo™ Bypass Graft Regulatory Class: II (Two) Product Code: 74 DSY Dated: October 29, 1998 Received: November 2, 1998

Dear Ms. Kistner:

We have reviewed your Section 510(k) notification of intent to market nte device referenced above and we have determined the device is ene dovers ally equivalent (for the indications for use stated in the enclosure) to 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). You provible fore, market the device, subject to the general controls may 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

{4}------------------------------------------------

Page 2 - Ms. Kristi M. Kistner

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Calla Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K983769 and K983861

Device Name: Impra Distaflo™ Bypass Graft

Indications For Use: Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bite R. Beaspele

(Division Sign-Off) Division of Cardiovascular Respiratory, and Neurological Devices

510(k) Number K993769/K993861

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K983861](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DSY/K983861)

**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. If you're preparing [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/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com