VANTAGE PERIPHERAL DILATATION CATHETER— 510(k) K965183

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K965183 for VANTAGE PERIPHERAL DILATATION CATHETER, Substantially Equivalent on 1997-04-24. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1996-12-24
Decision date: 1997-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, 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.