Cleared Traditional

CVSI PERIPHERAL BALLOON CATHETER (K022061) - FDA 510(k) Clearance

Also marketed or referenced as:
CVSI INFLATER

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

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

Submission Details

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.

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 K022061.
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · Medtronic Vascular · Dec 2002
8F LAUNCHER GUIDE CATHETER
K023402 · Medtronic Vascular · Nov 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · Cook, Inc. · Sep 2002
7F LAUNCHER GUIDE CATHETER
K022764 · Medtronic Vascular · Aug 2002
EQUALIZER BALLOON CATHETER
K021721 · Boston Scientific Corp · Jun 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · Cordis Corp. · Jun 2002