BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

K964814 · Bipore, Inc. · DYB · May 7, 1997 · Cardiovascular

Device Facts

• Record ID: K964814
• Device Name: BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
• Applicant: Bipore, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for percutaneous introduction of diagnostic and therapeutic devices into arteries and veins in patients requiring vascular access.

Regulatory Classification

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)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

**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.