K102176

Substantially Equivalent

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

Applicant: Medtronic Cryocath, LP
Product code: DRA
Advisory panel: Cardiovascular
Date received: 2010-08-03
Decision date: 2010-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Kirkland, CA

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.