Cleared Traditional

SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING (K935501) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935501 · Scimed Peripheral Interventions · Cardiovascular device
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Jan 1994
Decision
72d
Days
Class 2
Risk

K935501 is an FDA 510(k) clearance for the SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Scimed Peripheral Interventions (Plymouth, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 72 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 Scimed Peripheral Interventions devices

Submission Details

510(k) Number K935501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date January 27, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K935501.
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K930745 · B.Braun Medical, Inc. · May 1994
CORDIS OPTA 5(TM), MODIFICATION
K933236 · Cordis Corp. · Dec 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · Boston Scientific Corp · Dec 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · Boston Scientific Corp · Nov 1993