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

FDA 510(k)

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

K-Number: K172457 · 2018-06-28

ApplicantDeltex Medical Limited
Decision Date2018-06-28
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical Limited. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K172457. 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 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Deltex Medical Limited. The 510(k) number is K172457.

When did Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM receive FDA 510(k) clearance?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM received FDA 510(k) clearance on 2018-06-28, under 510(k) number K172457.

Who is the listed applicant for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

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

What is the FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is DPW.

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek 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)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.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)Remington Medical, 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.

↑