SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING— 510(k) K935501

Substantially Equivalent

Scimed Peripheral Interventions

FDA 510(k) clearance K935501 for SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING, Substantially Equivalent on 1994-01-27. Applicant: Scimed Peripheral Interventions.

Clearance details

Applicant: Scimed Peripheral Interventions
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1993-11-16
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.