FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K Number: K960446
·
Decision May 22, 1996
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
475
Review Days
111
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Basic Information
- Device Name
- MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
- K Number
- K960446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Vascular
- Date Received
- February 1, 1996
- Decision Date
- May 22, 1996
- 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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