Therapy and Therapy Dual-8 and Safire TX Ablation Catheter
FDA premarket approval P040042/S049 · decided 2021-03-24
Approval details
- PMA number
- P040042
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therapy and Therapy Dual-8 and Safire TX Ablation Catheter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- Date received
- 2021-02-25
- Decision date
- 2021-03-24
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of an alternative bacterial endotoxin test method.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER (K070011) | Irvine Biomedical,Inc.(Ibi) | 2007-03-20 |