Cleared Traditional

FOCUS PV BALLOON DILATATION CATHETER (K963688) - FDA 510(k) Clearance

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

K963688 · Cardiovascular Dynamics, Inc. · Cardiovascular device
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Mar 1997
Decision
193d
Days
Class 2
Risk

K963688 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 March 28, 1997 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Dynamics, Inc. devices

Submission Details

510(k) Number K963688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date March 28, 1997
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 K963688.
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
MAXI LD PTA BALLOON CATHETER
K963000 · Cordis Corp. · Feb 1997
CORDIS OPTA PTA BALLOON CATHETER
K962945 · Cordis Corp. · Oct 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · Boston Scientific Corp · Apr 1996