Cleared Traditional

K913112 - OPTI-PLAST 5F PTA CATHETERS

K913112 is an FDA 510(k) clearance for OPTI-PLAST 5F PTA CATHETERS, manufactured by Vas-Cath, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K913112 · Vas-Cath, Inc. · Cardiovascular device
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Aug 1991
Decision
42d
Days
Class 2
Risk

K913112 is an FDA 510(k) clearance for the OPTI-PLAST 5F PTA CATHETERS. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 16, 1991 after a review of 42 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 Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K913112

510(k) Number K913112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date August 16, 1991
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
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 261
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K913112.
TEGWIRE (TM)
K913391 · Boston Scientific Corp · Nov 1991
SUB-4(TM), PERIPHERAL DILATATION CATHETER
K913689 · Boston Scientific Corp · Oct 1991
BARD PERIPHERAL BALLOON DILATATION CATHETER
K910822 · C.R. Bard, Inc. · Aug 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K912984 · Vas-Cath, Inc. · Aug 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · Scimed Life Systems, Inc. · Aug 1991
CORDIS OPTA 5
K905698 · Cordis Corp. · Jul 1991