ClosureFast™ Endovenous Radiofrequency Ablation Catheter
FDA 510(k) clearance K223488 · decided 2023-03-23
Clearance details
- K-number
- K223488
- Device name
- ClosureFast™ Endovenous Radiofrequency Ablation Catheter
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-21
- Decision date
- 2023-03-23
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, 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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|---|---|---|
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| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |