The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Cathscanner(r) Visions(tm) 3.5f 54700/5.0f 54600.
| Device ID | K911384 |
| 510k Number | K911384 |
| Device Name: | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 |
| Classification | Echocardiograph |
| 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 | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-06-25 |