CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM— 510(k) K120086

Substantially Equivalent

Cardiosolutions

FDA 510(k) clearance K120086 for CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM, Substantially Equivalent on 2012-04-24. Applicant: Cardiosolutions.

Clearance details

Applicant: Cardiosolutions
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2012-01-11
Decision date: 2012-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, US

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Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.