Cleared Traditional

K201246 - PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) (FDA 510(k) Clearance)

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

K201246 · Qualimed USA, LLC · Cardiovascular device
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Aug 2021
Decision
452d
Days
Class 2
Risk

K201246 is an FDA 510(k) clearance for the PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ). Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Qualimed USA, LLC (Charlotte, US). The FDA issued a Cleared decision on August 3, 2021 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Qualimed USA, LLC devices

Submission Details

510(k) Number K201246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2020
Decision Date August 03, 2021
Days to Decision 452 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
327d slower than avg
Panel avg: 125d · This submission: 452d
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 Consultant

Alston & Bird, Llp
Marc J. Scheineson

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 401
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