The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Finecross Mg Coronary Micro-guide Catheter.
Device ID | K082519 |
510k Number | K082519 |
Device Name: | FINECROSS MG CORONARY MICRO-GUIDE CATHETER |
Classification | Catheter, Continuous Flush |
Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
Contact | Mark Unterreiner |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-09-02 |
Decision Date | 2008-09-26 |
Summary: | summary |