THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY
FDA premarket approval P060019/S027 · decided 2014-04-28
Approval details
- PMA number
- P060019
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2014-03-03
- Decision date
- 2014-04-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER (K082061) | Irvine Biomedical, Inc. | 2008-08-19 |
| INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER (K060757) | Irvine Biomedical, Inc. | 2006-04-19 |
| INQUIRY AFOCUS II DIAGNOSTIC CATHETER (K053582) | Irvine Biomedical, Inc. | 2006-03-21 |
| INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER (K042775) | Irvine Biomedical, Inc. | 2004-11-04 |
| AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 (K010471) | Irvine Biomedical, Inc. | 2001-06-06 |
| LUMA-CATH STEERABLE EP CATHETERS (K991878) | Irvine Biomedical, Inc. | 1999-12-10 |
| LUMA-CATH FIXED CURVE EP CATHETERS (K991025) | Irvine Biomedical, Inc. | 1999-10-15 |
| ORTHOGONAL EP CATHETERS (K990958) | Irvine Biomedical, Inc. | 1999-06-03 |