FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BDH BIPOLAR FEMORAL COMPONENT A3
K Number: K833404
·
Decision Mar 2, 1984
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
96
Applicant Total
22
Review Days
154
Basic Information
- Device Name
- BDH BIPOLAR FEMORAL COMPONENT A3
- K Number
- K833404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- CARBOMEDICS, INC.
- Date Received
- September 30, 1983
- Decision Date
- March 2, 1984
- Product Code
- KWY
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K960169 | CARBOMEDICS VALVE TESTER | Apr 15, 1996 | Substantially Equivalent |
| K955588 | VASCUTEK GRAFT SIZER SET | Mar 7, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Nov 29, 1995 | Substantially Equivalent |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Jun 20, 1995 | Substantially Equivalent |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Jul 6, 1994 | Substantially Equivalent |