The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Visions 2.9f Ultrasonic Imaging Catheter (model 84300).
| Device ID | K944004 |
| 510k Number | K944004 |
| Device Name: | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1995-05-04 |