Cleared Traditional

K131199 - ULTRAVERSE RX PTA BALLOON DILATATION CATHETER

K131199 is an FDA 510(k) clearance for ULTRAVERSE RX PTA BALLOON DILATATION CA..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K131199 · Bard Peripheral Vascular, Inc. · Cardiovascular device
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May 2013
Decision
34d
Days
Class 2
Risk

K131199 is an FDA 510(k) clearance for the ULTRAVERSE RX PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 30, 2013 after a review of 34 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 Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K131199

510(k) Number K131199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2013
Decision Date May 30, 2013
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 344
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