The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surflo(r) I.v. Catheter.
| Device ID | K891087 |
| 510k Number | K891087 |
| Device Name: | TERUMO SURFLO(R) I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1989-03-01 |
| Decision Date | 1989-06-23 |