The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Cathscanner(r) Intravascular Ultra Imaging System.
| Device ID | K893042 |
| 510k Number | K893042 |
| Device Name: | CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Contact | Adam D Savakus |
| Correspondent | Adam D Savakus ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-07-19 |