NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
FDA 510(k) clearance K033685 · decided 2004-08-03
Clearance details
- K-number
- K033685
- Device name
- NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
- Applicant
- Medical Cv, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-24
- Decision date
- 2004-08-03
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- KRH
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Inver Grove Heights, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S011) | Medical Cv, Inc. | 2002-10-29 |
| OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S007) | Medical Cv, Inc. | 2001-07-26 |
| OMNISCIENCE CARDIAC VALVE (P830039/S010) | Medical Cv, Inc. | 1999-10-29 |
| OMNISCIENCE CARDIAC VALVE PROSTHESIS (P830039/S009) | Medical Cv, Inc. | 1998-12-30 |
| OMNISCIENCE AND OMNICARBON CARDIAC VALVES (P830039/S008) | Medical Cv, Inc. | 1998-09-25 |
| OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE (P830039/S006) | Medical Cv, Inc. | 1997-03-26 |
| OMNISCEINCE PROSTHETIC CARDIAC VALVE (P830039/S002) | Medical Cv, Inc. | 1988-08-18 |
| OMNISCEINCE PROSTHETIC CARDIAC VALVE (P830039) | Medical Cv, Inc. | 1985-05-03 |