FlexCath Contour™ Steerable Sheath
FDA 510(k) clearance K232321 · decided 2023-10-31
Clearance details
- K-number
- K232321
- Device name
- FlexCath Contour™ Steerable Sheath
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-03
- Decision date
- 2023-10-31
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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