Cleared Special

K131332 - CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER

K131332 is an FDA 510(k) clearance for CARDIOSOLUTIONS PERCU-PRO STEERABLE INT..., manufactured by Cardiosolutions, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 71-day FDA review.

K131332 · Cardiosolutions, Inc. · Cardiovascular device
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Jul 2013
Decision
71d
Days
Class 2
Risk

K131332 is an FDA 510(k) clearance for the CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardiosolutions, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on July 19, 2013 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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.

View all Cardiosolutions, Inc. devices

FDA 510(k) Submission Details - K131332

510(k) Number K131332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2013
Decision Date July 19, 2013
Days to Decision 71 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 485
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K131332.
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