The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Terumo Surflash Safety I.v. Catheter.
| Device ID | K122544 |
| 510k Number | K122544 |
| Device Name: | TERUMO SURFLASH SAFETY I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TERUMO Corporation 1727-1, TSUIJIARAI, SHOWA-CHO NAKAKOMA-GUN Yamanashi, JP 409-3853 |
| Contact | Sandi Hartka |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2012-09-05 |
| Summary: | summary |