510(k) K972512— SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL

Substantially Equivalent

Boston Scientific Scimed, Inc.

Clearance details

Applicant: Boston Scientific Scimed, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1997-07-07
Decision date: 1998-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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.