Company ยท US
Mallinckrodt Critical Care
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1989. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 9 |
| FLL | Continuous Measurement Thermometer | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CFR | Hexokinase, Glucose | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| IYT | System, Rebreathing, Radionuclide | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| KOD | Catheter, Urological | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 1989 | K880343 | BURNEY GALLBLADDER CATHETER KIT Mallinckrodt Critical Care | FGE |
| Feb 2, 1988 | K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR Mallinckrodt Critical Care | KRI |
| Jan 29, 1988 | K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE Mallinckrodt Critical Care | FLL |
| Jan 6, 1988 | K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR Mallinckrodt Critical Care | FLL |
| Nov 6, 1987 | K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR Mallinckrodt Critical Care | FLL |
| Nov 6, 1987 | K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) Mallinckrodt Critical Care | BTR |
| Nov 3, 1987 | K873833 | THERMOCOUPLE ADAPTER Mallinckrodt Critical Care | FLL |
| Sep 15, 1987 | K873004 | GUIDING CATHETER Mallinckrodt Critical Care | DQO |
| Apr 21, 1987 | K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) Mallinckrodt Critical Care | BTR |
| Aug 1, 1986 | K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) Mallinckrodt Critical Care | BTR |
| Jul 31, 1986 | K862653 | LUER LOCK ADAPTER/NUT Mallinckrodt Critical Care | FPA |
| Jun 5, 1986 | K860901 | LASER RESISTANT TRACHEAL TUBE (TENTATIVE) Mallinckrodt Critical Care | BTR |
| May 15, 1986 | K861483 | ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) Mallinckrodt Critical Care | DQO |
| Jan 15, 1986 | K853182 | DIAGNOSTIC INTRAVASCULAR CATHETERS Mallinckrodt Critical Care | DQO |
| Sep 5, 1985 | K852413 | LGT TUBE Mallinckrodt Critical Care | BTO |
| Aug 13, 1985 | K852025 | BRANDT TRACHEAL TUBE(TENTATIVE) Mallinckrodt Critical Care | BTR |
| Jul 8, 1985 | K852493 | UNCUFFED HI-LO JET TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
| Jun 21, 1985 | K845037 | PERCUTANEOUS ANGIOGRAPHIC NEEDLES Mallinckrodt Critical Care | DYB |
| Mar 4, 1985 | K844201 | HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR Mallinckrodt Critical Care | FLL |
| Feb 1, 1985 | K844598 | LARIAT CATHETER Mallinckrodt Critical Care | DQO |
| Jan 14, 1985 | K843640 | XENON XE 127/XE 133 GAS DISPENSER Mallinckrodt Critical Care | IYT |
| Jul 26, 1984 | K841872 | UNCUFFED REINFORCED TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
| Jul 13, 1984 | K842113 | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT Mallinckrodt Critical Care | DRE |
| Jul 6, 1984 | K842464 | TRACHEAL TUBE/STETHOSCOPE Mallinckrodt Critical Care | BTR |
| Jun 22, 1984 | K842011 | CHLORIDE TEST KIT Mallinckrodt Critical Care | CHJ |
| Mar 16, 1984 | K840399 | FOAM NOSE Mallinckrodt Critical Care | BYD |
| Mar 16, 1984 | K840398 | INLINE FOAM NOSE Mallinckrodt Critical Care | BYD |
| Feb 13, 1984 | K834223 | CARDIOVASCULAR SPRING GUIDE WIRE Mallinckrodt Critical Care | DQX |
| Nov 7, 1983 | K832657 | DISPOSABLE MANIFOLD SET Mallinckrodt Critical Care | DRS |
| Oct 4, 1983 | K832635 | HI-LO TEMP TYMPANIC TEMP. SENSOR Mallinckrodt Critical Care | FLL |
| Sep 20, 1983 | K832553 | POTASSIUM TEST KIT Mallinckrodt Critical Care | CEJ |
| Sep 20, 1983 | K832552 | SODIUM TEST KIT Mallinckrodt Critical Care | CEI |
| Sep 1, 1983 | K832288 | HEMOGLOBINOMETER Mallinckrodt Critical Care | KMG |
| Aug 10, 1983 | K831567 | FOLEY-TEMP Mallinckrodt Critical Care | KOD |
| Jun 8, 1983 | K831509 | ANGIOGRAPHY KIT W/ADDIT. COMPONENTS Mallinckrodt Critical Care | DQO |
| May 9, 1983 | K830631 | TRACHEAL TUBE W/ILLUMINATING LOCATER Mallinckrodt Critical Care | BTR |
| Apr 28, 1983 | K830415 | DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Critical Care | DQO |
| Mar 9, 1983 | K830229 | ROENTGENOGRAPHY SET Mallinckrodt Critical Care | DGD |
| Mar 1, 1983 | K823886 | PROFILE 750 BLOOD CELL COUNTER Mallinckrodt Critical Care | GKL |
| Nov 3, 1982 | K822159 | ANGIOUROGRAPHY KIT Mallinckrodt Critical Care | FMF |
| Sep 28, 1982 | K822640 | CORONARY INFUSION KIT Mallinckrodt Critical Care | DQO |
| Jul 22, 1982 | K821151 | RIA-QUANT FPA TEST KIT Mallinckrodt Critical Care | DAN |
| Jul 20, 1982 | K821976 | ANGIOGRAPHY KIT Mallinckrodt Critical Care | DQO |
| Jul 20, 1982 | K821833 | HI-LO TEMP SKIN TEMPERATURE SENSOR Mallinckrodt Critical Care | FLL |
| Jun 1, 1982 | K820725 | SPAC T4 RIA TEST KIT Mallinckrodt Critical Care | CDX |
| Jan 29, 1982 | K820001 | CORONARY INFUSION KIT Mallinckrodt Critical Care | DQO |
| Oct 6, 1981 | K812690 | C-PEPTIDE CONTROL PACK Mallinckrodt Critical Care | JJX |
| Oct 6, 1981 | K812689 | RIA QUANT C-PEPTIDE KIT Mallinckrodt Critical Care | JKD |
| Aug 3, 1981 | K812000 | PEDIATRIC DOUBLE SWIVEL CONNECTOR Mallinckrodt Critical Care | BZA |
| Jul 23, 1981 | K811888 | LINDHOLM ANATOMICAL TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||