Cleared Special

MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K042541) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042541 · Cryo Vascular Systems, Inc. · Cardiovascular device
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Oct 2004
Decision
22d
Days
Class 2
Risk

K042541 is an FDA 510(k) clearance for the MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cryo Vascular Systems, Inc. (Los Gatos, US). The FDA issued a Cleared decision on October 12, 2004 after a review of 22 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. 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 Cryo Vascular Systems, Inc. devices

Submission Details

510(k) Number K042541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date October 12, 2004
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
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 Peers - DQY Catheter, Percutaneous

All 293
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K042541.
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EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp · Oct 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · Medtronic Vascular · Sep 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · Medtronic Vascular · May 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · Cook, Inc. · Apr 2004