Who is the manufacturer of BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER?

Bipore, Inc. filed the 510(k) submission for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K964814).

What is the FDA product code for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER?

DYB. It is classified under 21 CFR 870.1340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

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K040728 — ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT · AngioDynamics, Inc. · Jun 18, 2004
K240829 — AuST Steerable Sheath · CenterPoint Systems, LLC · May 1, 2024
K171146 — Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. · Arrow International, Inc. (Subsidiary of Telelflex Inc.) · Jun 23, 2017
K242106 — AuST Steerable Sheath · CenterPoint Systems, LLC · Oct 4, 2024

Submission Summary (Full Text)

{0} 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.