Company ยท US
Pudenz-Schulte Medical Research Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1996. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 18 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 3 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 |
| DXC | Clamp, Vascular | 1 |
| GWG | Endoscope, Neurological | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| GYK | Instrument, Shunt System Implantation | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 |
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 1996 | K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 Pudenz-Schulte Medical Research Corp. | LJS |
| Dec 18, 1995 | K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER Pudenz-Schulte Medical Research Corp. | LJS |
| Sep 18, 1995 | K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp. | JXG |
| Jul 14, 1994 | K934796 | IPI LOW PROFILE IMPORT Pudenz-Schulte Medical Research Corp. | LJT |
| Jul 14, 1994 | K934167 | IPI DUAL LUMEN PORT Pudenz-Schulte Medical Research Corp. | LJT |
| May 3, 1994 | K940096 | PS MEDICAL CATHETER PLACEMENT KIT Pudenz-Schulte Medical Research Corp. | GWG |
| Apr 28, 1994 | K934545 | PS MEDICAL DELTA BURR HOLE VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Feb 25, 1994 | K930206 | PS MEDICAL IPI ACCESS KIT Pudenz-Schulte Medical Research Corp. | LJT |
| Sep 10, 1993 | K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER Pudenz-Schulte Medical Research Corp. | GYK |
| Mar 30, 1993 | K913412 | PS MEDICAL CSF-ACCESS DEVICE Pudenz-Schulte Medical Research Corp. | JXG |
| Nov 20, 1992 | K922419 | IPI IMPORT Pudenz-Schulte Medical Research Corp. | LJT |
| Dec 30, 1991 | K915546 | PS MEDICAL VENTRICULOSTOMY KIT Pudenz-Schulte Medical Research Corp. | HBG |
| Jul 18, 1991 | K911382 | IPI ALGO-LINE CATHETER Pudenz-Schulte Medical Research Corp. | MAJ |
| Jun 28, 1991 | K911410 | PS MEDICAL BUTTON VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Oct 3, 1990 | K904283 | PS MEDICAL CRANIAL HAND DRILL Pudenz-Schulte Medical Research Corp. | HBG |
| Aug 8, 1990 | K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Apr 3, 1990 | K900676 | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 21, 1989 | K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR Pudenz-Schulte Medical Research Corp. | JXG |
| Feb 11, 1988 | K874498 | CSF-VENTRICULOSTOMY RESERVOIR Pudenz-Schulte Medical Research Corp. | LKG |
| Feb 11, 1988 | K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT Pudenz-Schulte Medical Research Corp. | LKG |
| Sep 18, 1987 | K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL Pudenz-Schulte Medical Research Corp. | JXG |
| May 22, 1987 | K871752 | CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 22, 1986 | K864754 | BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR Pudenz-Schulte Medical Research Corp. | |
| Dec 3, 1986 | K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE Pudenz-Schulte Medical Research Corp. | JXG |
| Aug 12, 1986 | K862303 | BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. Pudenz-Schulte Medical Research Corp. | JXG |
| May 25, 1984 | K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM Pudenz-Schulte Medical Research Corp. | LKG |
| Dec 8, 1983 | K832677 | P-S MEDICAL BERLIN VISADUCT KIT Pudenz-Schulte Medical Research Corp. | KOA |
| Aug 12, 1983 | K831396 | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT Pudenz-Schulte Medical Research Corp. | JXG |
| Jun 24, 1983 | K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR Pudenz-Schulte Medical Research Corp. | JXG |
| Mar 9, 1983 | K823503 | P-S CSF-VENTRICULAR CATHETER, FLANGED Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 16, 1982 | K823509 | P-S MED. LUMBO PERITONEAL & VENTRICULO- Pudenz-Schulte Medical Research Corp. | JXG |
| Apr 29, 1982 | K820949 | P-S BERLIN VESSEL CLAMP Pudenz-Schulte Medical Research Corp. | DXC |
| Mar 8, 1982 | K820474 | P-S SUCTION RESERVIOR Pudenz-Schulte Medical Research Corp. | GCY |
| Jan 5, 1982 | K813377 | PS-ROUND SURG. DRAIN & CONNECTOR Pudenz-Schulte Medical Research Corp. | GCY |
| Jan 22, 1981 | K803257 | CSG-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Sep 16, 1980 | K802100 | INTRACRANIAL PRESSURING MONITORING SYST. Pudenz-Schulte Medical Research Corp. | GWM |
| Jul 14, 1980 | K801443 | P-S SUCTION RESERVOIR Pudenz-Schulte Medical Research Corp. | GCY |
| Jul 14, 1980 | K801442 | P-S SURGICAL DRAIN Pudenz-Schulte Medical Research Corp. | GCY |
| Jan 16, 1980 | K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES Pudenz-Schulte Medical Research Corp. | JXG |
| Jan 16, 1980 | K792005 | CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. | JXG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||