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FDA 510(k)

Plexus SCD110 Sequential Compression Device Sleeve

K-Number: K190975 · 2019-07-22

ApplicantMidway Medical, LLC
Decision Date2019-07-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Plexus SCD110 Sequential Compression Device Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Midway Medical, LLC. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K190975. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plexus SCD110 Sequential Compression Device Sleeve?

Plexus SCD110 Sequential Compression Device Sleeve is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Midway Medical, LLC. The 510(k) number is K190975.

When did Plexus SCD110 Sequential Compression Device Sleeve receive FDA 510(k) clearance?

Plexus SCD110 Sequential Compression Device Sleeve received FDA 510(k) clearance on 2019-07-22, under 510(k) number K190975.

Who is the listed applicant for Plexus SCD110 Sequential Compression Device Sleeve?

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

What is the FDA product code for Plexus SCD110 Sequential Compression Device Sleeve?

The FDA product code for Plexus SCD110 Sequential Compression Device Sleeve is JOW.

Related Devices (Code: JOW)

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

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.

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