The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Heartrail Iii Guiding Catheter.
Device ID | K092372 |
510k Number | K092372 |
Device Name: | HEARTRAIL III GUIDING CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TERUMO 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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-08-05 |
Decision Date | 2009-09-11 |
Summary: | summary |