Cleared Traditional

K964814 - BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

K964814 is an FDA 510(k) clearance for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INT..., manufactured by Bipore, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K964814

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
Combination Product No
PCCP Authorized No
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.

DYB Device Classification - Class 2, Special Controls

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 611
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K964814.
PERCUTANEOUS VENOUS INTRODUCER 10264
K965167 · Medamicus, Inc. · Jul 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · Daig Corp. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997
EVS
K963886 · Applied Medical Resources · Apr 1997
GSI CANNULA WITH INTRODUCER
K970201 · General Surgical Innovations · Apr 1997