THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR
FDA premarket approval P060019/S005 · decided 2009-06-12
Approval details
- PMA number
- P060019
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2008-07-14
- Decision date
- 2009-06-12
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR USE OF THE COOL POINT PUMP AND TUBING SET TO PROVIDE IRRIGATION OF THE THERAPY COOL PATH ABLATION CATHETER AS WELL AS MODIFICATION TO THE IBI 1500T9 RF ABLATION GENERATOR TO FUNCTION WITH THE COOL POINT PUMP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IBI-1500T9-CP RF ABLATION 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 |