← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K964814

# BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K964814)

_Bipore, Inc. · DYB · May 7, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K964814

## Device Facts

- **Applicant:** Bipore, Inc.
- **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md)
- **Decision Date:** May 7, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The Bipore AccuFlex™ Percutaneous Sheath Introducer is designed to be used for the percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

## Device Story

Wire-reinforced flexible tube; features integral side port and hemostasis valve at proximal end. Used for percutaneous vascular access; facilitates introduction of diagnostic/therapeutic devices into arteries or veins. Operated by clinicians in clinical settings. Provides conduit for catheter/device placement; enables diagnostic or therapeutic interventions. Benefits patient by allowing minimally invasive vascular access.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Wire-reinforced flexible tube; integral side port; hemostasis valve. Class II device.

## Regulatory Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

## Predicate Devices

- Arrow Super Arrow-Flex™ Percutaneous Sheath Introducer ([K924607](/device/K924607.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.
>
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K964814
MAY - 7 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS
## BIPORE ACCUFLEX™ PERCUTANEOUS SHEATH INTRODUCER
### November 26, 1996

**Trade Name:** Bipore AccuFlex™ Percutaneous Sheath Introducer

**Manufacturer:** Bipore, Inc.
31 Industrial Parkway
Northvale, NJ 07647
Tel: (201) 767-1993  Fax: (201) 767-0435

**Device Generic Name:** Sheath Introducer

**Classification:** Class II, Performance Standards

**Predicate Device:** Arrow Super Arrow-Flex™ Percutaneous Sheath Introducer 510(k): K924607

**Description of Device:** The Bipore AccuFlex™ Percutaneous Sheath Introducer is a wire-reinforced flexible tube with an integral side port/hemostasis valve at the proximal end.

**Indications for Use:** The Bipore AccuFlex™ Percutaneous Sheath Introducer is designed to be used for the percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

**Safety and Performance:** Information concerning adverse health effects for this type of product is presented here and in the *Instructions for Use*. Generally, the potential complications for devices of this type are:

|  Vessel wall perforation | Bacteremia  |
| --- | --- |
|  Pleural and mediastinal injuries | Septicemia  |
|  Air embolism | Thrombosis  |
|  Thoracic duct laceration | Nerve damage  |
|  Inadvertant vessel puncture | Hematoma formation  |
|  Hemorrhage | Dysrythmias  |

**Conclusion:** Based on the indications for use, technological characteristics, and mechanical tests the Bipore AccuFlex™ Percutaneous Sheath Introducer is safe and effective for its intended use.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K964814](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K964814)

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