Pudenz-Schulte Medical Research Corp.
Mchenry, IL, US
Pudenz-Schulte Medical Research Corp. appears in FDA device records in Mchenry, IL. FDA records list 40 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 40
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 40 510(k) clearances for Pudenz-Schulte Medical Research Corp. between 1980 and 1996. The busiest year on record is 1980, with 5. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 5 |
| 1981 | 1 |
| 1982 | 4 |
| 1983 | 4 |
| 1984 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 5 |
| 1995 | 2 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 | LJS | Substantially Equivalent | |
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | LJS | Substantially Equivalent | |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | JXG | Substantially Equivalent | |
| K934796 | IPI LOW PROFILE IMPORT | LJT | Substantially Equivalent | |
| K934167 | IPI DUAL LUMEN PORT | LJT | Substantially Equivalent | |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | GWG | Substantially Equivalent | |
| K934545 | PS MEDICAL DELTA BURR HOLE VALVE | JXG | Substantially Equivalent | |
| K930206 | PS MEDICAL IPI ACCESS KIT | LJT | Unknown | |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | GYK | Substantially Equivalent | |
| K913412 | PS MEDICAL CSF-ACCESS DEVICE | JXG | Substantially Equivalent | |
| K922419 | IPI IMPORT | LJT | Substantially Equivalent | |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | HBG | Substantially Equivalent | |
| K911382 | IPI ALGO-LINE CATHETER | MAJ | Substantially Equivalent | |
| K911410 | PS MEDICAL BUTTON VALVE | JXG | Substantially Equivalent | |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | HBG | Substantially Equivalent | |
| K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE | JXG | Substantially Equivalent | |
| K900676 | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT | JXG | Substantially Equivalent | |
| K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR | JXG | Substantially Equivalent | |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | LKG | Substantially Equivalent | |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | LKG | Substantially Equivalent | |
| K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL | JXG | Substantially Equivalent | |
| K871752 | CSF-CARDIAC/PERITONEAL CATHETER | JXG | Substantially Equivalent | |
| K864754 | BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR | Substantially Equivalent | ||
| K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE | JXG | Substantially Equivalent | |
| K862303 | BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. | JXG | Substantially Equivalent | |
| K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | LKG | Substantially Equivalent | |
| K832677 | P-S MEDICAL BERLIN VISADUCT KIT | KOA | Substantially Equivalent | |
| K831396 | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT | JXG | Substantially Equivalent | |
| K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR | JXG | Substantially Equivalent | |
| K823503 | P-S CSF-VENTRICULAR CATHETER, FLANGED | JXG | Substantially Equivalent | |
| K823509 | P-S MED. LUMBO PERITONEAL & VENTRICULO- | JXG | Substantially Equivalent | |
| K820949 | P-S BERLIN VESSEL CLAMP | DXC | Substantially Equivalent | |
| K820474 | P-S SUCTION RESERVIOR | GCY | Substantially Equivalent | |
| K813377 | PS-ROUND SURG. DRAIN & CONNECTOR | GCY | Substantially Equivalent | |
| K803257 | CSG-FLOW CONTROL VALVE | JXG | Substantially Equivalent | |
| K802100 | INTRACRANIAL PRESSURING MONITORING SYST. | GWM | Substantially Equivalent | |
| K801443 | P-S SUCTION RESERVOIR | GCY | Substantially Equivalent | |
| K801442 | P-S SURGICAL DRAIN | GCY | Substantially Equivalent | |
| K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES | JXG | Substantially Equivalent | |
| K792005 | CSF-CARDIAC/PERITONEAL CATHETER | JXG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- MAJCatheter, Percutaneous, Intraspinal, Short Term
- DXCClamp, Vascular
- GWMDevice, Monitoring, Intracranial Pressure
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- GWGEndoscope, Neurological
- GYKInstrument, Shunt System Implantation
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular
- JXGShunt, Central Nervous System And Components
- KOASurgical Instruments, G-U, Manual (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
