Cleared Traditional

FOCUS PC BALLOON DILATATION CATHETER (K954313) - FDA 510(k) Clearance

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

K954313 · Cardio-Dynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
77d
Days
Class 2
Risk

K954313 is an FDA 510(k) clearance for the FOCUS PC BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cardio-Dynamics, Inc. (Irvine, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 77 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 Cardio-Dynamics, Inc. devices

Submission Details

510(k) Number K954313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date December 01, 1995
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K954313.
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K960517 · C.R. Bard, Inc. · Apr 1996
MEGA PTA BALLOON CATHETER
K955886 · Cordis Corp. · Mar 1996
COURIER BALLOON DILATATION CATHETER
K953569 · Boston Scientific Corp · Dec 1995
XXL BALLON DILATATION CATHETER
K952063 · Boston Scientific Corp · Nov 1995
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
K953602 · Boston Scientific Corp · Oct 1995
BRAUN PTA BALLOON CATHETER
K951248 · B.Braun Medical, Inc. · Jun 1995