FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
K Number: K965251
·
Decision Mar 18, 1997
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
5
Applicant Total
468
Review Days
89
Basic Information
- Device Name
- MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
- K Number
- K965251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- December 19, 1996
- Decision Date
- March 18, 1997
- Product Code
- MAJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | FDA class 2 | Anesthesiology |
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