The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Guide Wire M.
Device ID | K923607 |
510k Number | K923607 |
Device Name: | RADIFOCUS GUIDE WIRE M |
Classification | Catheter, Urological |
Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-16 |
Decision Date | 1992-10-02 |