Pudenz-Schulte Medical Research Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 40
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 | September 30, 1996 |
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | December 18, 1995 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | September 18, 1995 |
| K934167 | IPI DUAL LUMEN PORT | July 14, 1994 |
| K934796 | IPI LOW PROFILE IMPORT | July 14, 1994 |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | May 3, 1994 |
| K934545 | PS MEDICAL DELTA BURR HOLE VALVE | April 28, 1994 |
| K930206 | PS MEDICAL IPI ACCESS KIT | February 25, 1994 |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | September 10, 1993 |
| K913412 | PS MEDICAL CSF-ACCESS DEVICE | March 30, 1993 |
| K922419 | IPI IMPORT | November 20, 1992 |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | December 30, 1991 |
| K911382 | IPI ALGO-LINE CATHETER | July 18, 1991 |
| K911410 | PS MEDICAL BUTTON VALVE | June 28, 1991 |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | October 3, 1990 |
| K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE | August 8, 1990 |
| K900676 | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT | April 3, 1990 |
| K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR | December 21, 1989 |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | February 11, 1988 |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | February 11, 1988 |