The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for 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 T.
| Device ID | K173912 |
| 510k Number | K173912 |
| Device Name: | 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 T |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Donna M. Semlak |
| Correspondent | Donna M. Semlak Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55019517103586 | K173912 | 000 |
| 55019517103418 | K173912 | 000 |
| 35019517103407 | K173912 | 000 |
| 35019517103391 | K173912 | 000 |
| 55019517103388 | K173912 | 000 |
| 35019517103377 | K173912 | 000 |
| 35019517103360 | K173912 | 000 |
| 55019517103357 | K173912 | 000 |
| 35019517103346 | K173912 | 000 |
| 55019517103333 | K173912 | 000 |
| 35019517103322 | K173912 | 000 |
| 55019517103319 | K173912 | 000 |
| 35019517103308 | K173912 | 000 |
| 35019517103292 | K173912 | 000 |
| 35019517082658 | K173912 | 000 |
| 55019517103425 | K173912 | 000 |
| 35019517103438 | K173912 | 000 |
| 55019517103579 | K173912 | 000 |
| 55019517103562 | K173912 | 000 |
| 35019517103551 | K173912 | 000 |
| 35019517103544 | K173912 | 000 |
| 35019517103537 | K173912 | 000 |
| 55019517103524 | K173912 | 000 |
| 35019517103513 | K173912 | 000 |
| 35019517103506 | K173912 | 000 |
| 35019517103490 | K173912 | 000 |
| 35019517103483 | K173912 | 000 |
| 35019517103476 | K173912 | 000 |
| 35019517103469 | K173912 | 000 |
| 35019517103452 | K173912 | 000 |
| 35019517103445 | K173912 | 000 |
| 35019517082641 | K173912 | 000 |