Cleared Traditional

K960517 - BARD TRU-TRAC PERIPHERAL BALLOON DILATA...

K960517 is the FDA 510(k) clearance for BARD TRU-TRAC PERIPHERAL BALLOON DILATA... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K960517 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
64d
Days
Class 2
Risk

K960517 is an FDA 510(k) clearance for the BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 9, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K960517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date April 09, 1996
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K960517.
MAXI LD PTA BALLOON CATHETER
K963000 · Cordis Corp. · Feb 1997
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K962945 · Cordis Corp. · Oct 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · Boston Scientific Corp · Apr 1996
MEGA PTA BALLOON CATHETER
K955886 · Cordis Corp. · Mar 1996
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K952884 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996
MS CLASSIQUE BALLOON DIATATION CATHETER
K953298 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996