Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

K-Number: K212065 · 2021-10-07

ApplicantRemington Medical, Inc.
Decision Date2021-10-07
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is a medical device manufactured by Remington Medical, Inc.. It received FDA 510(k) clearance on 2021-10-07 under approval number K212065. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is a medical device that received FDA 510(k) clearance on 2021-10-07. It is manufactured by Remington Medical, Inc.. The 510(k) number is K212065.

When was VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger approved by the FDA?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger received FDA 510(k) clearance on 2021-10-07, under approval number K212065.

What company makes VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is manufactured by Remington Medical, Inc..

What is the FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

The FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is DPW.

Related Clinical Trials

NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING NCT07576998 PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial NOT_YET_RECRUITING NCT05809427 High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT05362032 Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate SUSPENDED NCT07516470 Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients RECRUITING

Other Devices by Remington Medical, Inc.

K191315Remington Medical, Inc. Automatic Cutting Needle (NAC) K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger K241583VascuChek 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) K251904VascuChek 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)

Related Devices (Code: DPW)

K152930PeriFlux6000Perimed AB K181269iCertaintyRfpi K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare , Ltd. K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) K182494FlowMet-RLaser Associated Sciences, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑