The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Open Ended Guidewire.
Device ID | K880332 |
510k Number | K880332 |
Device Name: | MEDRAD OPEN ENDED GUIDEWIRE |
Classification | Wire, Guide, Catheter |
Applicant | MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
Contact | Ruey C Dempsey |
Correspondent | Ruey C Dempsey MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-26 |
Decision Date | 1988-07-28 |