FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
K Number: K952184
·
Decision Nov 29, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
6
Applicant Total
22
Review Days
204
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Basic Information
- Device Name
- CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
- K Number
- K952184
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.3945
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carbomedics, Inc.
- Date Received
- May 9, 1995
- Decision Date
- November 29, 1995
- 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 |
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Other Clearances by Carbomedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | Jul 25, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | Feb 19, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K962154 | CARBOMEDICS HANDLE | Aug 27, 1996 | Substantially Equivalent |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Apr 29, 1996 | Substantially Equivalent |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | Apr 25, 1996 | Unknown |
| K960169 | CARBOMEDICS VALVE TESTER | Apr 15, 1996 | Substantially Equivalent |
| K955588 | VASCUTEK GRAFT SIZER SET | Mar 7, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Jun 20, 1995 | Substantially Equivalent |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Jul 6, 1994 | Substantially Equivalent |
| K934951 | VALVE SIZER | Dec 10, 1993 | Substantially Equivalent |