Cleared Traditional

K971448 - CORDIS OPTA LP PTA BALLOON CATHETER

K971448 is an FDA 510(k) clearance for CORDIS OPTA LP PTA BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971448 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
73d
Days
Class 2
Risk

K971448 is an FDA 510(k) clearance for the CORDIS OPTA LP PTA BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 73 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 Cordis Corp. devices

FDA 510(k) Submission Details - K971448

510(k) Number K971448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date July 03, 1997
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K971448.
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · Boston Scientific Corp · Nov 1997
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER
K971516 · Cordis Corp. · Jul 1997
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · Cordis Corp. · Jul 1997
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