FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10— 510(k) K102176
Substantially EquivalentMedtronic 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. Device class: 2.
Clearance details
- Applicant
- Medtronic Cryocath, LP
- Product code
- Code DRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1280
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kirkland, CA
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More clearances from Medtronic Cryocath, LP
view allAdverse events under product code DRA
product code DRA- Death
- 156
- Injury
- 3,133
- Malfunction
- 6,266
- Total
- 9,555
Source: openFDA MAUDE database, through . 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.