FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENODYNE DVT ADVANTAGE MODEL 610
K Number: K001802
·
Decision Jan 9, 2001
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
24
Review Days
209
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Basic Information
- Device Name
- VENODYNE DVT ADVANTAGE MODEL 610
- K Number
- K001802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microtek Medical, Inc.
- Date Received
- June 14, 2000
- Decision Date
- January 9, 2001
- 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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|---|---|---|---|
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| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | May 16, 2002 | Substantially Equivalent |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Nov 18, 1994 | Substantially Equivalent |