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 |