Epicardial Access System
FDA 510(k) clearance K213582 · decided 2022-06-30
Clearance details
- K-number
- K213582
- Device name
- Epicardial Access System
- Applicant
- Baylis Medical Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-12
- Decision date
- 2022-06-30
- Days to decision
- 230 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.