POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM— 510(k) K030742

Substantially Equivalent

Cryo Vascular Systems, Inc.

FDA 510(k) clearance K030742 for POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM, Substantially Equivalent on 2003-08-29. Applicant: Cryo Vascular Systems, Inc..

Clearance details

Applicant: Cryo Vascular Systems, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2003-03-10
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.