ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.— 510(k) K903582

Substantially Equivalent

Catheter Sciences Co.

FDA 510(k) clearance K903582 for ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH., Substantially Equivalent on 1990-11-06. Applicant: Catheter Sciences Co..

Clearance details

Applicant: Catheter Sciences Co.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1990-08-08
Decision date: 1990-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Brunswick, NJ, US

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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.