Cleared Traditional

K022061 - CVSI PERIPHERAL BALLOON CATHETER

Also marketed or referenced as:
CVSI INFLATER

K022061 is an FDA 510(k) clearance for CVSI PERIPHERAL BALLOON CATHETER, manufactured by Cryo Vascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K022061 · Cryo Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
87d
Days
Class 2
Risk

K022061 is an FDA 510(k) clearance for the CVSI PERIPHERAL BALLOON CATHETER. 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 September 20, 2002 after a review of 87 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 Cryo Vascular Systems, Inc. devices

FDA 510(k) Submission Details - K022061

510(k) Number K022061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2002
Decision Date September 20, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 705
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K022061.
8F LAUNCHER GUIDE CATHETER
K023402 · Medtronic Vascular · Nov 2002
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K022552 · Cook, Inc. · Sep 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
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PTA AND PTV
K022722 · NuMED, Inc. · Sep 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · Guidant Corp. · Sep 2002
7F LAUNCHER GUIDE CATHETER
K022764 · Medtronic Vascular · Aug 2002