VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
FDA 510(k) clearance K211589 · decided 2022-01-27
Clearance details
- K-number
- K211589
- Device name
- VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- Applicant
- Remington Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-24
- Decision date
- 2022-01-27
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| BlueDop Vascular Expert (K260700) | BlueDop Medical, Ltd. | 2026-07-08 |
| FloPatch FP120 (K252810) | Flosonics Medical | 2026-04-24 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) (K251904) | Remington Medical, Inc. | 2025-11-20 |
| FloPatch FP120 (K251114) | Flosonics Medical | 2025-06-20 |
| Elfor-L (K243852) | Elfi-Tech , Ltd. | 2025-04-14 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) (K241583) | Remington Medical, Inc. | 2024-08-30 |
| FloPatch FP120 (K223843) | Flosonics Medical | 2023-05-03 |
| FloPatch FP120 (K222242) | Flosonics Medical | 2022-12-09 |
| GEM FLOW COUPLER Monitor (GEM1020M-2) (K213974) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (K212065) | Remington Medical, Inc. | 2021-10-07 |
| Bidop 7 (K201114) | Koven Technology, Inc. | 2021-01-05 |
| FloPatch (FP120) (K200337) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 |
Recalls involving this device
No recalls on record reference this clearance.