Cleared Traditional

CVSI PERIPHERAL BALLOON CATHETER (K023463) - FDA 510(k) Clearance

Also marketed or referenced as:
CVSI CATHETER INFLATION UNIT

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

K023463 · Cryo Vascular Systems, Inc. · Cardiovascular device
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Feb 2003
Decision
127d
Days
Class 2
Risk

K023463 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 February 19, 2003 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryo Vascular Systems, Inc. devices

Submission Details

510(k) Number K023463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date February 19, 2003
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K023463.
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K030779 · Medtronic Vascular · Apr 2003
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · Medtronic Vascular · Dec 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · Medtronic Vascular · Dec 2002
8F LAUNCHER GUIDE CATHETER
K023402 · Medtronic Vascular · Nov 2002