Stoeckert Instrumente
Arvada, CO, US
Stoeckert Instrumente appears in FDA device records in Arvada, CO. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Stoeckert Instrumente between 1982 and 2001. The busiest year on record is 1996, with 3. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | DWF | Substantially Equivalent | |
| K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE | DWF | Substantially Equivalent | |
| K002118 | STOCKERT COMPACT SYSTEM VERSION 2.0 | DTQ | Substantially Equivalent | |
| K992635 | INTERFACE MODULE IDDD | KRI | Substantially Equivalent | |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | KRI | Substantially Equivalent | |
| K982014 | STOCKERT COMPACT SYSTEM | DTQ | Substantially Equivalent | |
| K972321 | S3 MAST PUMP | DWB | Substantially Equivalent | |
| K971520 | S3 CYCLIC RPM CONTROL | DWB | Substantially Equivalent | |
| K962320 | S3 CARDIOPLEGIA CONTROL | DTR | Substantially Equivalent | |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | DTW | Substantially Equivalent | |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | DWB | Substantially Equivalent | |
| K950990 | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE | DTQ | Substantially Equivalent | |
| K812049 | STOCKERT CARDIAC PACING ELECTRODES | DTB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DTBPermanent Pacemaker Electrode
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
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