Medtronic PS Medical
Goleta, CA, US
Medtronic PS Medical appears in FDA device records in Goleta, CA. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Medtronic PS Medical between 1996 and 2002. The busiest year on record is 2001, with 4. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012052 | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 | JXG | Substantially Equivalent | |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | GXR | Substantially Equivalent | |
| K010487 | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 | GEI | Substantially Equivalent | |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | GWG | Substantially Equivalent | |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | GWG | Substantially Equivalent | |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | GWG | Substantially Equivalent | |
| K991502 | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 | JXG | Substantially Equivalent | |
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | GWG | Substantially Equivalent | |
| K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | |
| K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | GWM | Substantially Equivalent | |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | HCA | Substantially Equivalent | |
| K981046 | MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 | JXG | Substantially Equivalent | |
| K970341 | MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT | LIS | Substantially Equivalent | |
| K961336 | MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652 | LJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain