VANGUARD REPROCESSED COMPRESSION GARMENT
FDA 510(k) clearance K012403 · decided 2001-10-17
Clearance details
- K-number
- K012403
- Device name
- VANGUARD REPROCESSED COMPRESSION GARMENT
- Applicant
- Vanguard Medical Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-30
- Decision date
- 2001-10-17
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lakeland, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting ster recall (Z-1661-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressibl recall (Z-1666-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb slee recall (Z-1671-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve. recall (Z-1672-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |
| Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve. recall (Z-1676-2008) | Ascent Healthcare Solutions, Inc. | 2008-09-19 |