POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM— 510(k) K042230

Name: FDA 510(k) clearance K042230
Creator: U.S. Food and Drug Administration
Published: 2004-11-05

Substantially Equivalent

Cryo Vascular Systems, Inc.

FDA 510(k) clearance K042230 for POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM, Substantially Equivalent on 2004-11-05. Applicant: Cryo Vascular Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cryo Vascular Systems, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2004-08-17
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

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K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from Cryo Vascular Systems, Inc.

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K051916 — POLAR CATH PERIPHERAL DILATATION SYSTEM2005-08-05
K042541 — MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM2004-10-12
K033622 — POLARCATH PERIPHERAL DILATATION SYSTEM2004-02-10
K030742 — POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM2003-08-29
K023463 — CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT2003-02-19

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.