Cleared Special

K121856 - ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION

K121856 is an FDA 510(k) clearance for ULTRAVERSE 014 AND 018 PTA BALLOON DILA..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 15-day FDA review.

K121856 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
15d
Days
Class 2
Risk

K121856 is an FDA 510(k) clearance for the ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 11, 2012 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121856

510(k) Number K121856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date July 11, 2012
Days to Decision 15 days
Submission Type Special
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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 402
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K121856.
ATLAS GOLD PTA DILATATION CATHETER
K122984 · C.R. Bard, Inc. · Oct 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
K122379 · Ostial Corporation · Sep 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
K122070 · Trireme Medical, Inc. · Aug 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
K121175 · Ostial Corporation · Jun 2012
VECTOR
K121385 · R4 Vascular, Inc. · Jun 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K121442 · Cordis Corporation · Jun 2012
K121856 · ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
Download PDF FDA Summary C.R. Bard, Inc.