The following data is part of a premarket notification filed by Intertherapy, Inc. with the FDA for Intravascular Imaging System.
| Device ID | K895159 |
| 510k Number | K895159 |
| Device Name: | INTRAVASCULAR IMAGING SYSTEM |
| Classification | Angioscope |
| Applicant | INTERTHERAPY, INC. 1001 W. 17TH ST. - SUITE D Costa Mesa, CA 92627 |
| Contact | Paul Zalesky |
| Correspondent | Paul Zalesky INTERTHERAPY, INC. 1001 W. 17TH ST. - SUITE D Costa Mesa, CA 92627 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-23 |
| Decision Date | 1990-03-12 |