The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Hybria Closed System Safety I.v. Catheter.
| Device ID | K082997 |
| 510k Number | K082997 |
| Device Name: | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Eileen Dorsey |
| 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 | 2008-10-08 |
| Decision Date | 2009-04-15 |
| Summary: | summary |