Cleared Special

K073434 - BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

K073434 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 Special 510(k) pathway after a 117-day FDA review.

K073434 · Bipore, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
117d
Days
Class 2
Risk

K073434 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 April 1, 2008 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073434

510(k) Number K073434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2007
Decision Date April 01, 2008
Days to Decision 117 days
Submission Type Special
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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

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 706
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K073434.
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · Terumo Medical Corp. · May 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · Thomas Medical Products, Inc. · May 2008
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
K080500 · Acumen Medical, Inc. · Mar 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp. · Mar 2008
K073434 · BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
Download PDF FDA Summary Bipore, Inc.