510(k) K173384 ยท BTO Tube, Tracheostomy (W/Wo Connector)
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
| Applicant | Smiths Medical Ads, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 10, 2018 |
| Received | Oct 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2024 | Smiths Medical ASD Inc. smiths medical portex BLUselect, tracheostomy tube, labeled as follows:
1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ;
2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 10 Open, Classified |
BTO | None listed |
| Sep 11, 2024 | Smiths Medical ASD Inc. smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows:
1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm Open, Classified |
BTO | None listed |
| Sep 11, 2024 | Smiths Medical ASD Inc. smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:
1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator Open, Classified |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.