FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10— 510(k) K102176

Substantially Equivalent

Medtronic Cryocath, LP

FDA 510(k) clearance K102176 for FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10, Substantially Equivalent on 2010-09-01. Applicant: Medtronic Cryocath, LP.

Clearance details

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

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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.