Mallinckrodt Critical Care
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 92
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K880343 | BURNEY GALLBLADDER CATHETER KIT | May 1, 1989 |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | February 2, 1988 |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | January 29, 1988 |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | January 6, 1988 |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | November 6, 1987 |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | November 6, 1987 |
| K873833 | THERMOCOUPLE ADAPTER | November 3, 1987 |
| K873004 | GUIDING CATHETER | September 15, 1987 |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | April 21, 1987 |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | August 1, 1986 |
| K862653 | LUER LOCK ADAPTER/NUT | July 31, 1986 |
| K860901 | LASER RESISTANT TRACHEAL TUBE (TENTATIVE) | June 5, 1986 |
| K861483 | ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) | May 15, 1986 |
| K853182 | DIAGNOSTIC INTRAVASCULAR CATHETERS | January 15, 1986 |
| K852413 | LGT TUBE | September 5, 1985 |
| K852025 | BRANDT TRACHEAL TUBE(TENTATIVE) | August 13, 1985 |
| K852493 | UNCUFFED HI-LO JET TRACHEAL TUBE | July 8, 1985 |
| K845037 | PERCUTANEOUS ANGIOGRAPHIC NEEDLES | June 21, 1985 |
| K844201 | HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR | March 4, 1985 |
| K844598 | LARIAT CATHETER | February 1, 1985 |