The following data is part of a premarket notification filed by Terumo Bct, Inc. with the FDA for T-cuff.
| Device ID | K162365 |
| 510k Number | K162365 |
| Device Name: | T-Cuff |
| Classification | Tourniquet, Pneumatic |
| Applicant | Terumo BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215 |
| Contact | Nithya Rajan |
| Correspondent | Nithya Rajan Terumo BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583712522 | K162365 | 000 |