The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Luma-cath Fixed Curve Ep Catheters.
| Device ID | K991025 |
| 510k Number | K991025 |
| Device Name: | LUMA-CATH FIXED CURVE EP CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612 |
| Contact | Roger Tu |
| Correspondent | Roger Tu IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-10-15 |
| Summary: | summary |