Panels › Anesthesiology › Product code BTR · Class 2
Tube, Tracheal (W/Wo Connector)
Regulation 868.5730
2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1984 | K842464 | TRACHEAL TUBE/STETHOSCOPE Mallinckrodt Critical Care | BTR |
| May 25, 1984 | K840943 | ENDO-JECT Autovage | BTR |
| Mar 30, 1984 | K840973 | COLE TUBE-LATEX Inmed Corp. | BTR |
| Mar 21, 1984 | K833831 | 3-DAY BIOINDICATOR RELEASE FOR STERIL Shiley, Inc. | BTR |
| Jan 13, 1984 | K833807 | ARGYLE JET TRACHEAL TUBE Sherwood Medical Co. | BTR |
| Oct 28, 1983 | K833197 | TRACH SWIVE/CONNECTOR Airlife, Inc. | BTR |
| Sep 20, 1983 | K832629 | INTUBATION KIT Calbio, Inc. | BTR |
| May 9, 1983 | K830631 | TRACHEAL TUBE W/ILLUMINATING LOCATER Mallinckrodt Critical Care | BTR |
| Apr 28, 1983 | K823757 | SURGITEK ENDOTRACHEAL TUBE, LASER RESIS Medical Engineering Corp. | BTR |
| Apr 12, 1983 | K830504 | SURGITEK ULTRA-LO CUFF Mec/Surgitek Products | BTR |
| Mar 8, 1983 | K830352 | REINFORCED SILICONE TRACHEAL TUBE Portex, Inc. | BTR |
| Aug 10, 1982 | K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp. | BTR |
| Jun 24, 1982 | K821670 | ARGYLE TARTAN I TRACHEAL TUBE Sherwood Medical Co. | BTR |
| Jun 17, 1982 | K821456 | ENDOTRACHEAL TUBE Life-Line Products, Inc. | BTR |
| May 21, 1982 | K821243 | ENDOTRACHEAL TUBE Life-Line Products, Inc. | BTR |
| May 21, 1982 | K821180 | TRACELON Terumo Medical Corp. | BTR |
| May 3, 1982 | K821027 | SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL Shiley, Inc. | BTR |
| Dec 22, 1981 | K813373 | VYGON ENDOTRACHEAL TUBES Exco, Inc. | BTR |
| Nov 24, 1981 | K812880 | OHIO NON-REUSABLE TRACHEAL TUBE MAJILL Airco/Ohio Medical Products | BTR |
| Nov 24, 1981 | K812879 | OHIO NON-REUSABLE TRACHEAL TUBE MURPHY Airco/Ohio Medical Products | BTR |
| Nov 6, 1981 | K812943 | SLICK ENDOTRACHEAL TUBE Polamedco, Inc. | BTR |
| Jul 31, 1981 | K811937 | ARGYLE TARTAN TRACHEAL TUBE Sherwood Medical Co. | BTR |
| Jul 23, 1981 | K811888 | LINDHOLM ANATOMICAL TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
| Mar 27, 1981 | K810763 | OHIO DISPOSABLE TRACHEAL TUBE Airco/Ohio Medical Products | BTR |
| Mar 13, 1981 | K802505 | DOUBLE LUMEN TRACHEAL TUBE National Catheter Co. Div. Mallinckrodt | BTR |
| Feb 12, 1981 | K810151 | SLICK SET W/SURELOC EXTERNAL CONNECTOR Polamedco, Inc. | BTR |
| May 28, 1980 | K801213 | CONCEPT ENDOTRACHEAL TUBE Concept, Inc. | BTR |
| May 23, 1980 | K801005 | MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) National Catheter Co. Div. Mallinckrodt | BTR |
| Apr 2, 1980 | K800634 | OHIO DISPOSABLE TRACHEAL TUBE Ohio Medical Products | BTR |
| Oct 26, 1979 | K792035 | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE Bivona Medical Technologies | BTR |
| Jun 13, 1979 | K791046 | ENDOTRACHEAL TUBES, LONG & SHORT TERM Extracorporeal Medical Specialities, Inc. | BTR |
| Jun 13, 1979 | K791045 | MODEL GV-10 LANZ PRESSURE-VALVE Extracorporeal Medical Specialities, Inc. | BTR |
| May 21, 1979 | K790927 | OXYGENERATOR NO. M-049 Mem Medical, Inc. | BTR |
| Apr 13, 1979 | K790575 | TUBE, ARMORED TRACHEAL National Patent Development Corp. | BTR |
| Feb 21, 1979 | K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR Respiratory Support Products, Inc. | BTR |
| Dec 12, 1978 | K781713 | ADAPTER, C/D SUCTION Novametrix Medical Systems, Inc. | BTR |
| Nov 29, 1978 | K781808 | SLICK SET, CUFFED Polamedco, Inc. | BTR |
| Aug 15, 1978 | K781339 | ENDOTRACHEAL TUBE Life-Line Products, Inc. | BTR |
| Jul 17, 1978 | K780900 | SLICK SET Polamedco, Inc. | BTR |
| May 12, 1978 | K780583 | FOME-CUF PVC Bivona Medical Technologies | BTR |
| Aug 16, 1977 | K771197 | NORTON ENDOTRACHEAL V. Mueller O.V. Baxter Healthcare Corp. | BTR |
| Nov 19, 1976 | K760998 | ENDOTRACHAEL TUBE AND HOLDER Mcgaw Respiratory Therapy | BTR |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.