RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER— 510(k) K993639

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K993639 for RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, Substantially Equivalent on 2000-01-27. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1999-10-28
Decision date: 2000-01-27
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.