FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DVT-PRO
K Number: K203353
·
Decision Apr 22, 2021
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
14
Review Days
160
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Basic Information
- Device Name
- DVT-PRO
- K Number
- K203353
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daesung Maref Co., Ltd.
- Date Received
- November 13, 2020
- Decision Date
- April 22, 2021
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
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Other Clearances by Daesung Maref Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231437 | LF900 | Jul 19, 2023 | Substantially Equivalent |
| K202395 | SP-1000, SP-2000 | Sep 1, 2021 | Substantially Equivalent |
| K203498 | LX9max | Jul 2, 2021 | Substantially Equivalent |
| K203019 | LF900 | Jun 22, 2021 | Substantially Equivalent |
| K203417 | DVT-4000S | Mar 28, 2021 | Substantially Equivalent |
| K203016 | DVT-2600 | Dec 5, 2020 | Substantially Equivalent |
| K160178 | Lympha-Flow(LF1200) | Jan 11, 2017 | Substantially Equivalent |
| K160180 | Intermittent Pneumatic Compression system | Nov 3, 2016 | Substantially Equivalent |
| K150980 | Venous Assist System | May 12, 2016 | Substantially Equivalent |
| K150033 | Air Compressible Limb Therapy System | Apr 20, 2015 | Substantially Equivalent |