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FDA 510(k)

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

K-Number: K212065 · 2021-10-07

Decision Date2021-10-07
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) 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. The listed applicant is Remington Medical, Inc.. The 510(k) number is K212065.

When did VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger receive FDA 510(k) clearance?

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

Who is the listed applicant for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

The FDA 510(k) record lists Remington Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Remington Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DPW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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