Cleared Abbreviated

K051513 - BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

K051513 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 Abbreviated 510(k) pathway after a 188-day FDA review.

K051513 · Bipore, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
188d
Days
Class 2
Risk

K051513 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 December 7, 2005 after a review of 188 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bipore, Inc. devices

FDA 510(k) Submission Details - K051513

510(k) Number K051513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date December 07, 2005
Days to Decision 188 days
Submission Type Abbreviated
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
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Standards-based clearance path.

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 K051513.
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
K053400 · Acumen Medical, Inc. · Jun 2006
INTRODUCER ASSEMBLY WITH ROTATOR LOCK
K060519 · Teleflex Medical · May 2006
SUPER SHEATH XL INTRODUCER SHEATH
K060190 · Togo Medikit Co., Ltd. · Apr 2006
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · St Jude Medical · Dec 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005