FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K Number: K923407
·
Decision Oct 19, 1992
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
475
Review Days
101
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Basic Information
- Device Name
- MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
- K Number
- K923407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Vascular
- Date Received
- July 10, 1992
- Decision Date
- October 19, 1992
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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