Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
FDA 510(k) clearance K240787 · decided 2024-09-12
Clearance details
- K-number
- K240787
- Device name
- Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-22
- Decision date
- 2024-09-12
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.