FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
METRONIC MODEL F7700 HEART VALVE SIZERS
K Number: K852612
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
6
Applicant Total
475
Review Days
96
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Basic Information
- Device Name
- METRONIC MODEL F7700 HEART VALVE SIZERS
- K Number
- K852612
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.3945
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- June 19, 1985
- Decision Date
- September 23, 1985
- Product Code
- DTI
- 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 |
|---|---|---|---|
| DTI | Sizer, Heart-Valve, Prosthesis | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTI), ordered by most recent decision date.
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HANCOCK * OBTURATORS
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