The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Glidewire Gt With Gold Coil,glidewire Gold.
Device ID | K955801 |
510k Number | K955801 |
Device Name: | RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD |
Classification | Wire, Guide, Catheter |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Keith M Smith |
Correspondent | Keith M Smith TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-22 |
Decision Date | 1996-02-02 |