Polystan C/O Vitalcor, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K894657 | POLYSTAN HEART-LUNG MACHINE SYSTEM | March 28, 1990 |
| K893940 | POLYSTAN HEATER-COOLER UNIT | January 18, 1990 |
| K893704 | SAFE-1 | December 22, 1989 |
| K893705 | SAFE-1 VENOUS RESERVOIR | December 22, 1989 |
| K874852 | POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS | February 5, 1988 |
| K874853 | POLYSTAN TWO STAGE CATHETERS | February 5, 1988 |
| K872182 | POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE | October 30, 1987 |
| K843538 | PO 2 LYTRODE | October 18, 1984 |