FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
K Number: K140092
·
Decision Apr 16, 2014
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
13
Review Days
92
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Basic Information
- Device Name
- CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
- K Number
- K140092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Currie Medical Specialties, Inc.
- Date Received
- January 14, 2014
- Decision Date
- April 16, 2014
- 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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Other Clearances by Currie Medical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151158 | ALP VasQcare Take Home System | Dec 10, 2015 | Substantially Equivalent |
| K143317 | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) | Jan 20, 2015 | Substantially Equivalent |
| K112311 | ALP 501 RB PUMP SYSTEM | Sep 1, 2011 | Substantially Equivalent |
| K902441 | DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) | Aug 23, 1990 | Unknown |
| K874760 | CK 4900 SERIES, GOWN AND TOWEL PAK | Dec 10, 1987 | Substantially Equivalent |
| K872395 | CK 1600 SERIES, TOWELS | Jul 2, 1987 | Substantially Equivalent |
| K871737 | CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR | Jun 22, 1987 | Substantially Equivalent |
| K864816 | CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE | Jan 8, 1987 | Substantially Equivalent |
| K864697 | CK 6000 SERIES, TOWELS | Dec 18, 1986 | Substantially Equivalent |
| K834558 | CK10000 SERIES POUCH & BAGS ETC. | Sep 5, 1984 | Substantially Equivalent |