510(k) K881279
- Device
- Edwards-duromedics Bileaflet Valve Sizer Set
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K881279
- Product code
- DTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-18
- Date received
- 1988-03-22
- Regulation
- 870.3945
- Classification name
- Sizer, Heart-Valve, Prosthesis
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN L ELY
- Address
- P O Box 11150 Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 1063481
- 3011137372
- 1646747
- 2031093
- 3007113487
- 1836161
- 9617601
- 3010041511
- 3001883144
- 2135147
- 2025587
- 3038284086
- 9615005
- 3005687633
- 8043385
- 1720929
- 2015691
- 1723241
- 3010805418
- 3008500478
- 8010697
- 1649833
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Carbomedics, Inc. | 1995-11-29 |
| K934951 | VALVE SIZER | Carbomedics, Inc. | 1993-12-10 |
| K853313 | DUROMEDICS CARDIAC VALVE SIZER SET | Hemex Scientific, Inc. | 1985-11-01 |
| K852612 | METRONIC MODEL F7700 HEART VALVE SIZERS | Medtronic Vascular | 1985-09-23 |
| K820887 | MITRAL VALVE ORIFICE SIZER | Celtech | 1982-07-08 |
| K801885 | HANCOCK * OBTURATORS | Hancock Laboratories, Inc. | 1980-09-09 |