FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
K Number: K051438
·
Decision Apr 4, 2006
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
11
Review Days
307
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Basic Information
- Device Name
- VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
- K Number
- K051438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliance Medical, Inc.
- Date Received
- June 1, 2005
- Decision Date
- April 4, 2006
- 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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PlasmaFlow X Compression Sleeve Device (XPF0001)
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Other Clearances by Alliance Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Sep 23, 2005 | Substantially Equivalent |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Sep 24, 2003 | Substantially Equivalent |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Feb 5, 2003 | Substantially Equivalent |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Jun 24, 2002 | Substantially Equivalent |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Nov 9, 2001 | Substantially Equivalent |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K012613 | REPROCSSED LINVATEC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K990198 | AMIB7 | Jun 29, 1999 | Substantially Equivalent |
| K951976 | ECHO. AKHO | Jul 26, 1996 | Substantially Equivalent |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Feb 3, 1994 | Substantially Equivalent |