VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more— 510(k) K251904

Name: FDA 510(k) clearance K251904
Creator: U.S. Food and Drug Administration
Published: 2025-11-20

Substantially Equivalent

Remington Medical, Inc.

FDA 510(k) clearance K251904 for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more, Substantially Equivalent on 2025-11-20. Applicant: Remington Medical, Inc.. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Remington Medical, Inc.
Product code: Product code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2025-06-20
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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