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 |