The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Cathscanner Intravascular Ultrasonic Imaging Syst..
| Device ID | K883888 |
| 510k Number | K883888 |
| Device Name: | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. |
| Classification | Echocardiograph |
| Applicant | ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Contact | Faden, Phd |
| Correspondent | Faden, Phd ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1988-12-12 |