The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Inquiry H-curve Tv Steerable Diagnostic Catheter.
| Device ID | K082061 |
| 510k Number | K082061 |
| Device Name: | INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Contact | Jeanette Hendrickson |
| Correspondent | Jeanette Hendrickson IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine, CA 92614 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2008-08-19 |
| Summary: | summary |