MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM— 510(k) K092455

Name: FDA 510(k) clearance K092455
Creator: U.S. Food and Drug Administration
Published: 2009-09-04

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K092455 for MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM, Substantially Equivalent on 2009-09-04. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2009-08-10
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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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.