510(k) K173912 ยท JOH Tube Tracheostomy And Tube Cuff
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
| Applicant | Smiths Medical Asd, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, May 8, 2018 |
| Received | Dec 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173912
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.