Cleared Traditional

K970725 - OPTI-PLAST XL 5.5 F PTA CATHETER

K970725 is an FDA 510(k) clearance for OPTI-PLAST XL 5.5 F PTA CATHETER, 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 70-day FDA review.

K970725 · Vas-Cath, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
70d
Days
Class 2
Risk

K970725 is an FDA 510(k) clearance for the OPTI-PLAST XL 5.5 F PTA CATHETER. 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 May 9, 1997 after a review of 70 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 - K970725

510(k) Number K970725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1997
Decision Date May 09, 1997
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 K970725.
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · Cordis Corp. · Jun 1997
ULTRAVERSE PTA CATHETER
K964881 · Vas-Cath, Inc. · May 1997
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953647 · Meadox Medicals, Div. Boston Scientific Corp. · May 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · Cordis Corp. · May 1997
CHANNEL BALLOON CATHETER
K970379 · Boston Scientific Corp · May 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · Guidant Corp. · Apr 1997