Cleared Traditional

K942400 - BARD PERIPHERAL BALLOON DILATATION CATH...

K942400 is the FDA 510(k) clearance for BARD PERIPHERAL BALLOON DILATATION CATH... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K942400 · C.R. Bard, Inc. · Cardiovascular device
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Nov 1994
Decision
172d
Days
Class 2
Risk

K942400 is an FDA 510(k) clearance for the BARD 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 November 7, 1994 after a review of 172 days - an extended review 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: 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 K942400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date November 07, 1994
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 K942400.
NOPROFILE OLBERT CATHETER SYSTEM
K944989 · Meadox Medicals, Div. Boston Scientific Corp. · Apr 1995
POWERFLEX(TM) 5F PTA BALLOON CATHETER
K946052 · Cordis Corp. · Mar 1995
SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K944815 · Scimed Life Systems, Inc. · Nov 1994
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · Cordis Corp. · Nov 1994
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1994
MS CLASSIQUE BALLOON CATHETER
K942293 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1994