The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Endosonics Automatic Pull Back Device.
| Device ID | K962293 |
| 510k Number | K962293 |
| Device Name: | ENDOSONICS AUTOMATIC PULL BACK DEVICE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1996-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000327 | K962293 | 000 |