The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Radifocus Guide Wire.
Device ID | K863138 |
510k Number | K863138 |
Device Name: | TERUMO RADIFOCUS GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Harald Jacoby |
Correspondent | Harald Jacoby 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 | 1986-08-15 |
Decision Date | 1986-11-20 |