INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
FDA 510(k) clearance K042775 · decided 2004-11-04
Clearance details
- K-number
- K042775
- Device name
- INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
- Applicant
- Irvine Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-06
- Decision date
- 2004-11-04
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, 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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| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S047) | Irvine Biomedical, Inc. | 2022-12-16 |