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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 1995 | K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION Rusch, Inc. | BTS |
| Jun 8, 1995 | K951091 | RUSCH ENDOBRONCHIAL TUBE SETS Rusch Intl. | BTS |
| Aug 3, 1990 | K902116 | MODIFIED ENDOBRONCHIAL TUBE Concord/Portex | BTS |
| Jan 17, 1984 | K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE Portex, Inc. | BTS |
| Dec 27, 1983 | K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF Surgitek | BTS |
| Aug 4, 1977 | K771219 | BRONCHO-CATH Mallinckrodt Critical Care | BTS |
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