Cleared Traditional

SCIMED MAVERICK (K934793) - FDA 510(k) Clearance

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

K934793 · Scimed Peripheral Interventions · Cardiovascular device
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Jan 1994
Decision
91d
Days
Class 2
Risk

K934793 is an FDA 510(k) clearance for the SCIMED MAVERICK. 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 5, 1994 after a review of 91 days - within the typical 510(k) review window.

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 Scimed Peripheral Interventions devices

Submission Details

510(k) Number K934793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1993
Decision Date January 05, 1994
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K934793.
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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