Cleared Special

K133569 - TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

K133569 is an FDA 510(k) clearance for TRUE DILATATION BALLOON VALVULOPLASTY C..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Special 510(k) pathway after a 30-day FDA review.

K133569 · Bard Peripheral Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
30d
Days
Class 2
Risk

K133569 is an FDA 510(k) clearance for the TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, .... Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1255 - 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 - K133569

510(k) Number K133569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date December 20, 2013
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OZT Device Classification - Class 2, Special Controls

Product Code OZT Balloon Aortic Valvuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1255
Definition A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
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 - OZT Balloon Aortic Valvuloplasty

All 21
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K133569.
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · C.R. Bard, Inc. · Sep 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · Edwards Lifesciences, LLC · Jul 2014
V8 TRANSLUMINAL BAV CATHETER
K133607 · Intervalve, Inc. · Feb 2014
V8 TRANSLUMINAL BAV CATHETER
K132728 · Intervalve, Inc. · Nov 2013
V8 TRANSLUMINAL BAV CATHETER
K123111 · Intervalve, Inc. · Jan 2013
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
K121083 · Loma Vista Medical · Oct 2012
K133569 · TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
Download PDF FDA Summary Bard Peripheral Vascu…