FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
ANNULOFLO SYSTEM
K Number: K970375
·
Decision Jul 25, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
22
Review Days
172
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Basic Information
- Device Name
- ANNULOFLO SYSTEM
- K Number
- K970375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Carbomedics, Inc.
- Date Received
- February 3, 1997
- Decision Date
- July 25, 1997
- Product Code
- KRH
- 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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | FDA class 2 | Cardiovascular |
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Other Clearances by Carbomedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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. |
| 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 |
| K934951 | VALVE SIZER | Dec 10, 1993 | Substantially Equivalent |