Panels › Anesthesiology › Product code BTS · Class 2
Tube, Bronchial (W/Wo Connector)
Regulation 868.5720
0510(k)s in 12 months (6 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in BTS
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex, Inc. | 0 | 9 |
| Teleflex Medical | 0 | 2 |
| Concord/Portex | 1 | 0 |
| Mallinckrodt Critical Care | 1 | 0 |
| Portex, Inc. | 1 | 0 |
| Rusch, Inc. | 1 | 0 |
| Rusch Intl. | 1 | 0 |
| Surgitek | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. White Bronchial Double Lumen Tube Set (Right) Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Tracheopart Set (Right), Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Tracheopart Set (Left), Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Carlens Bronchial Double Lumen Tube Set (Left) Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Bronchial One Lumen Tube - Right Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Bronchial One Lumen Tube - Left Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Right), Sterile Terminated |
BTS | K951091 |
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Left), Sterile Terminated |
BTS | K951091 |
| Mar 19, 2014 | Teleflex Medical Rusch Brochopart and Rusch Brochopart White
The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, b Terminated |
BTS | K951091 |
| Nov 2, 2006 | Teleflex Medical Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; H Terminated |
BTS | K961977 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.