Cleared Traditional

FOCUS-PV BALLOON DILATATION CATHETER (K971577) - FDA 510(k) Clearance

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

K971577 · Cardiovascular Dynamics, Inc. · Cardiovascular device
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Jun 1997
Decision
58d
Days
Class 2
Risk

K971577 is an FDA 510(k) clearance for the FOCUS-PV BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cardiovascular Dynamics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 18, 1997 after a review of 58 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 Cardiovascular Dynamics, Inc. devices

Submission Details

510(k) Number K971577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date June 18, 1997
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 152
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K971577.
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · Cordis Corp. · Jul 1997
CORDIS OPTA LP PTA BALLOON CATHETER
K971448 · Cordis Corp. · Jul 1997
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · Cordis Corp. · Jun 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · Cordis Corp. · May 1997
CHANNEL BALLOON CATHETER
K970379 · Boston Scientific Corp · May 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · Cordis Corp. · Apr 1997