Cleared Traditional

K123544 - RAPIDCROSS PTA RAPID EXCHANGE

K123544 is the FDA 510(k) clearance for RAPIDCROSS PTA RAPID EXCHANGE by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K123544 · Ev3, Inc. · Cardiovascular device
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Feb 2013
Decision
85d
Days
Class 2
Risk

K123544 is an FDA 510(k) clearance for the RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 12, 2013 after a review of 85 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 Ev3, Inc. devices

Submission Details

510(k) Number K123544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date February 12, 2013
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

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 236
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K123544.
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · Ev3, Inc. · May 2013
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K130786 · C.R. Bard, Inc. · May 2013
PASSEO-35
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K123358 · Medtronic Vascular · Jan 2013
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K122984 · C.R. Bard, Inc. · Oct 2012
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
K121856 · C.R. Bard, Inc. · Jul 2012