SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER— 510(k) K953602

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K953602 for SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER, Substantially Equivalent on 1995-10-18. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1995-08-02
Decision date: 1995-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, 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.