SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER
FDA premarket approval P060019/S021 · decided 2012-07-10
Approval details
- PMA number
- P060019
- Supplement
- S021
- Supplement type
- Real-Time Process
- Trade name
- SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2012-05-11
- Decision date
- 2012-07-10
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATIVE PACKAGE CONFIGURATION FOR THE SUBJECT ABLATION CATHETERS. THE NEW PACKAGE CONFIGURATION WOULD CHANGE THE PREVIOUS COILED TRAY CONFIGURATION TO A TRAY WITH A STRAIGHT CONFIGURATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU SP IRRIGATED ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER, AND SAFIRE BLU DUO SP ABLATION CATHETER.
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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 |