510(k) K951091 ยท BTS Tube, Bronchial (W/Wo Connector)
RUSCH ENDOBRONCHIAL TUBE SETS
| Applicant | Rusch Intl., Jeffrey NH, US |
| Decision | Substantially Equivalent, Jun 8, 1995 |
| Received | Mar 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Left), Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Right), Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Bronchial One Lumen Tube - Left Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Bronchial One Lumen Tube - Right Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Carlens Bronchial Double Lumen Tube Set (Left) Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Tracheopart Set (Left), Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Tracheopart Set (Right), Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. White Bronchial Double Lumen Tube Set (Right) Sterile Terminated |
BTS | None listed |
| Aug 18, 2015 | Teleflex, Inc. Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Terminated |
BTS | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.