Cleared Traditional

K964814 - BIPORE ACCUFLEX PERCUTANEOUS SHEATH INT...

K964814 is the FDA 510(k) clearance for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INT... by Bipore, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K964814 · Bipore, Inc. · Cardiovascular device
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May 1997
Decision
159d
Days
Class 2
Risk

K964814 is an FDA 510(k) clearance for the BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Bipore, Inc. (Northvale, US). The FDA issued a Cleared decision on May 7, 1997 after a review of 159 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bipore, Inc. devices

Submission Details

510(k) Number K964814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date May 07, 1997
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 393
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K964814.
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TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997
EVS
K963886 · Applied Medical Resources · Apr 1997
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K962978 · Johnson & Johnson Medical, Inc. · Jan 1997