HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
FDA 510(k) clearance K101111 · decided 2010-06-18
Clearance details
- K-number
- K101111
- Device name
- HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
- Applicant
- Barrx Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-21
- Decision date
- 2010-06-18
- Days to decision
- 58 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator an recall (Z-2745-2011) | Barrx Medical, Inc. | 2011-07-06 |