The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Visions 8.2f Pv Ultrasonic Imaging Catheter (model 88900).
| Device ID | K982329 |
| 510k Number | K982329 |
| Device Name: | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ENDOSONICS CORP. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Adam D Savakus |
| Correspondent | Adam D Savakus ENDOSONICS CORP. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1999-01-14 |
| Summary: | summary |