The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Endosonics Trak Back Device.
| Device ID | K990271 |
| 510k Number | K990271 |
| Device Name: | ENDOSONICS TRAK BACK DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | ENDOSONICS CORP. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Richard Hebert |
| Correspondent | Richard Hebert ENDOSONICS CORP. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-28 |
| Decision Date | 1999-08-30 |
| Summary: | summary |