Cleared Traditional

K942094 - CORDIS SAVVY PTA BALLOON CATHETER

K942094 is an FDA 510(k) clearance for CORDIS SAVVY PTA BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K942094 · Cordis Corp. · Cardiovascular device
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Nov 1994
Decision
183d
Days
Class 2
Risk

K942094 is an FDA 510(k) clearance for the CORDIS SAVVY PTA BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 183 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 Cordis Corp. devices

FDA 510(k) Submission Details - K942094

510(k) Number K942094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date November 01, 1994
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K942094.
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
BARD PERIPHERAL BALLOON DILATATION CATHETER
K942400 · C.R. Bard, Inc. · Nov 1994
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1994
OPTI-PLAST ANGIOPLASTY CATHETER
K941706 · Vas-Cath, Inc. · Oct 1994
MS CLASSIQUE BALLOON CATHETER
K942293 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1994