FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED FEMORAL COMPRESSION DEVICE
K Number: K120204
·
Decision Apr 3, 2012
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
64
Review Days
71
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Basic Information
- Device Name
- REPROCESSED FEMORAL COMPRESSION DEVICE
- K Number
- K120204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- January 23, 2012
- Decision Date
- April 3, 2012
- Product Code
- NMF
- 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 |
|---|---|---|---|
| NMF | Clamp, Vascular, Reprocessed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NMF), ordered by most recent decision date.
REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
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