Cleared Traditional

K910996 - OPTI-PLAST 5F PTA CATHETERS

K910996 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 36-day FDA review.

K910996 · Vas-Cath, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
36d
Days
Class 2
Risk

K910996 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 April 9, 1991 after a review of 36 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 - K910996

510(k) Number K910996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1991
Decision Date April 09, 1991
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 K910996.
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE
K911639 · Vas-Cath, Inc. · Jun 1991
STEALTH CATHETER SYSTEM
K911089 · Target Therapeutics · May 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · Boston Scientific Corp · Apr 1991
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991
OWENS CATHETER
K896520 · Boston Scientific Corp · Mar 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1991