The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echomark Guidewire With Ultrasonic Localization.
| Device ID | K922787 |
| 510k Number | K922787 |
| Device Name: | ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION |
| Classification | Wire, Guide, Catheter |
| Applicant | ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Contact | De Bernardis |
| Correspondent | De Bernardis ECHOCATH, INC. P.O. BOX 7224 Princeton, NJ 08543 -7224 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1993-01-06 |