FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPROCESSED HEART STABILIZERS AND POSITIONERS
K Number: K063844
·
Decision Mar 15, 2007
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
64
Review Days
79
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Basic Information
- Device Name
- REPROCESSED HEART STABILIZERS AND POSITIONERS
- K Number
- K063844
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- December 26, 2006
- Decision Date
- March 15, 2007
- Product Code
- NQG
- 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 |
|---|---|---|---|
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQG), ordered by most recent decision date.
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
FDA 510(k)
FDA Class 1
·Cardiovascular
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
FDA 510(k)
FDA Class 1
·Cardiovascular
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