Cleared Traditional

BARD PTV DILATATION CATHETER (K122367) - FDA 510(k) Clearance

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

K122367 · C.R. Bard, Inc. · Cardiovascular device
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Nov 2012
Decision
88d
Days
Class 2
Risk

K122367 is an FDA 510(k) clearance for the BARD PTV DILATATION CATHETER. Classified as Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter (product code OMZ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 88 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K122367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date November 02, 2012
Days to Decision 88 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMZ Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition Catheter Is Used For Percutaneous Transluminal Or Balloon Valvuloplasty (ptv) Of The Pulmonary (pulmonic) Valve. Used On Patients With Isolated Pulmonary Stenosis And Also On Patients With Valvular Pulmonary Stenosis With Other Minor Congenital Heart Disease That Does Not Require Surgical Intervention.
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.