The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Heartrail Iii Guiding Catheter.
Device ID | K113335 |
510k Number | K113335 |
Device Name: | HEARTRAIL III GUIDING CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | TERUMO Corporation 44-1, 2-CHOME HATAGAYA Shibuya-ku Tokyo, JP 151-0072 |
Contact | Mark Unterreiner |
Correspondent | Mark Unterreiner TERUMO Corporation 44-1, 2-CHOME HATAGAYA Shibuya-ku Tokyo, JP 151-0072 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-14 |
Decision Date | 2012-07-16 |
Summary: | summary |