Cleared Traditional

K960445 - INPUT TUOHY-BORST LOCKING DEVICE

K960445 is the FDA 510(k) clearance for INPUT TUOHY-BORST LOCKING DEVICE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K960445 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
193d
Days
Class 2
Risk

K960445 is an FDA 510(k) clearance for the INPUT TUOHY-BORST LOCKING DEVICE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 12, 1996 after a review of 193 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K960445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date August 12, 1996
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K960445.
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · Johnson & Johnson Medical, Inc. · Jan 1997
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · Cordis Corp. · Oct 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · B.Braun Medical, Inc. · Sep 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · C.R. Bard, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · B.Braun Medical, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K955820 · B.Braun Medical, Inc. · Mar 1996