B-Capta
FDA 510(k) clearance K202154 · decided 2021-04-01
Clearance details
- K-number
- K202154
- Device name
- B-Capta
- Applicant
- Livanova Deutschland, GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-08-03
- Decision date
- 2021-04-01
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.