REEFLEX PTA CATHETER— 510(k) K101361

Substantially Equivalent

ClearStream Technologies , Ltd.

FDA 510(k) clearance K101361 for REEFLEX PTA CATHETER, Substantially Equivalent on 2010-08-04. Applicant: ClearStream Technologies , Ltd..

Clearance details

Applicant: ClearStream Technologies , Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2010-05-14
Decision date: 2010-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enniscorthy, County Wexford, IE

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.