Peripheral Systems Group
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | June 10, 1994 |
| K934433 | VANTAGE DIALTAION CATHETER | December 9, 1993 |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | October 7, 1993 |
| K931327 | PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE | July 14, 1993 |
| K915554 | HI-TORQUE SPORT-T(TM) GUIDE WIRE | February 9, 1993 |
| K914979 | EDM(R) INFUSION CATHETER | September 16, 1992 |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | February 27, 1992 |
| K915168 | PROFLEX 5 | February 19, 1992 |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | December 27, 1991 |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | December 17, 1991 |
| K904984 | ADVANCE 418(TM) | April 12, 1991 |
| K904959 | PSG HEMOSTATIC CONTROL VALVE | December 17, 1990 |
| K903625 | DOPPLER NEEDLE AND FLOW MONITOR | November 7, 1990 |
| K895179 | ACCESSOR PERIPHERAL DILATING GUIDE WIRE | February 28, 1990 |
| K895146 | GUIDING CATHETER | January 19, 1990 |
| K894944 | BALLOON DILATATION CATHETER | January 19, 1990 |
| K895932 | PSG(TM) EDM(TM) INFUSION CATHETER | January 4, 1990 |