← Back to catalogue

Dvt-Pro

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K203353

by Daesung Maref Co., Ltd.

Identity

Trade Name
DVT-PRO FDA UDI
Generic Name
Sequential venous compression system FDA UDI
Device Name
Main device 1ea, Tubing (81cm) 2ea, Tubing (102cm) 2ea [One set box] FDA UDI
Model / Reference
DVTP200-2 FDA UDI
Description
Main device 1ea, Tubing (81cm) 2ea, Tubing (102cm) 2ea [One set box] FDA UDI

Identifiers

Primary DI / UDI-DI
08809802644458 FDA UDI
510(k) Number
K203353 FDA 510(k)FDA UDI
FDA Product Code
JOW FDA 510(k)FDA UDI
GMDN Term
Sequential venous compression system FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dvt-Pro by Daesung Maref Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Daesung Maref Co., Ltd.

Sources (2)

  • FDA 510(k) K203353 24 fields · synced Jun 18, 2026
  • FDA UDI 900c7653-b416-450c-b3fb-317e21266cd5 34 fields · synced May 27, 2026