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FDA 510(k)

DVT-PRO

K-Number: K203353 · 2021-04-22

ApplicantDaesung Maref Co., Ltd.
Decision Date2021-04-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DVT-PRO is a medical device manufactured by Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-04-22 under approval number K203353. 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 DVT-PRO?

DVT-PRO is a medical device that received FDA 510(k) clearance on 2021-04-22. It is manufactured by Daesung Maref Co., Ltd.. The 510(k) number is K203353.

When was DVT-PRO approved by the FDA?

DVT-PRO received FDA 510(k) clearance on 2021-04-22, under approval number K203353.

What company makes DVT-PRO?

DVT-PRO is manufactured by Daesung Maref Co., Ltd..

What is the FDA product code for DVT-PRO?

The FDA product code for DVT-PRO is JOW.

Other Devices by Daesung Maref Co., Ltd.

K160180Intermittent Pneumatic Compression system K150980Venous Assist System K160178Lympha-Flow(LF1200) K203016DVT-2600 K202395SP-1000, SP-2000 K203498LX9max

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Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

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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