FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K Number: K031210
·
Decision May 16, 2003
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
4
Review Days
29
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Basic Information
- Device Name
- MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
- K Number
- K031210
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Metronic, Inc.
- Date Received
- April 17, 2003
- Decision Date
- May 16, 2003
- Product Code
- DTB
- 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
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