Last synced on 30 September 2022 at 11:05 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173912
510(k) Type
Traditional
Applicant
Smiths Medical ASD, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2018
Days to Decision
137 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173912
510(k) Type
Traditional
Applicant
Smiths Medical ASD, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2018
Days to Decision
137 days
Submission Type
Summary