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 |