The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Support Catheter.
| Device ID | K110540 |
| 510k Number | K110540 |
| Device Name: | TERUMO SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-25 |
| Decision Date | 2011-05-13 |
| Summary: | summary |