The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Surshield- Pur Safety I.v. Catheter.
| Device ID | K100282 |
| 510k Number | K100282 |
| Device Name: | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TERUMO CORP. 950 ELKTON BOULEVARD Elkton, MD 21921 |
| Contact | Christina Flanagan |
| Correspondent | Christina Flanagan TERUMO CORP. 950 ELKTON BOULEVARD 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 | 2010-02-01 |
| Decision Date | 2010-02-26 |
| Summary: | summary |