IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
FDA premarket approval P060019 · decided 2007-03-16
Approval details
- PMA number
- P060019
- Trade name
- IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2006-05-30
- Decision date
- 2007-03-16
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE THERAPY COOL PATH ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY COOL PATH ABLATION CATHETER IS INTENDED FOR USE WITH A COMPATIBLE EXTERNAL INFUSION PUMP AND THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WI
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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 |