The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Vascuchek Kit, Vascuchek Transceiver, Vascuchek Surgical Probe, Vascuchek Charger.
| Device ID | K211589 |
| 510k Number | K211589 |
| Device Name: | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
| Contact | Caitlin Senter |
| Correspondent | Matt Brown Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2022-01-27 |