The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Surshield Safety I.v. Catheter (18g X 51mm & 20g X 51mm Sizes).
| Device ID | K090973 |
| 510k Number | K090973 |
| Device Name: | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Lynne Witkowski |
| Correspondent | Lynne Witkowski TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-05-01 |
| Summary: | summary |