FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K Number: K885101
·
Decision Jan 12, 1989
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
101
Applicant Total
468
Review Days
31
Basic Information
- Device Name
- MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
- K Number
- K885101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- December 12, 1988
- Decision Date
- January 12, 1989
- Product Code
- DSA
- 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 |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
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