Cleared Traditional

K042230 - POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

K042230 is an FDA 510(k) clearance for POLARCATH PERIPHERAL BALLOON CATHETER S..., 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 80-day FDA review.

K042230 · Cryo Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
80d
Days
Class 2
Risk

K042230 is an FDA 510(k) clearance for the POLARCATH PERIPHERAL BALLOON CATHETER 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 November 5, 2004 after a review of 80 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.

FDA 510(k) Submission Details - K042230

510(k) Number K042230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date November 05, 2004
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 893
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K042230.
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K042910 · Velocimed, Inc. · Nov 2004
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
K042537 · Invatec Innovative Technologies · Nov 2004
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
K042538 · Invatec Innovative Technologies · Nov 2004
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
K042388 · Radiant Medical · Oct 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp · Oct 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541 · Cryo Vascular Systems, Inc. · Oct 2004
K042230 · POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
Download PDF FDA Summary Cryo Vascular Systems…