The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Terufusion Blood & Y-type Admin. Set.
| Device ID | K854446 |
| 510k Number | K854446 |
| Device Name: | TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Harold Jacoby |
| Correspondent | Harold Jacoby TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-01-09 |