The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo(r) Arterial And Venous Blood Line Set.
| Device ID | K910558 |
| 510k Number | K910558 |
| Device Name: | TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | George S Momoda |
| Correspondent | George S Momoda TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-08 |
| Decision Date | 1991-08-07 |