LUMA-CATH FIXED CURVE EP CATHETERS
FDA 510(k) clearance K991025 · decided 1999-10-15
Clearance details
- K-number
- K991025
- Device name
- LUMA-CATH FIXED CURVE EP CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-29
- Decision date
- 1999-10-15
- Days to decision
- 200 days
- Clearance type
- Special
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cool Point Tubing Set (P060019/S058) | Irvine Biomedical, Inc. | 2025-12-19 |
| IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S057) | Irvine Biomedical, Inc. | 2025-05-28 |
| Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables (P040014/S050) | Irvine Biomedical, Inc. | 2025-04-10 |
| Therapy Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19- (P040014/S049) | Irvine Biomedical, Inc. | 2024-10-15 |
| Cool Point Tubing Set (P060019/S056) | Irvine Biomedical, Inc. | 2024-05-22 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P040014/S048) | Irvine Biomedical, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P060019/S055) | Irvine Biomedical, Inc. | 2023-11-29 |
| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S047) | Irvine Biomedical, Inc. | 2022-12-16 |