FDA Product Code KTR: Tube, Aspirating, Bronchoscope, Rigid
If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
Leading manufacturers include Sherwood Medical Co., Kelleher Corp. and Ballard Medical Products.
4
Total
4
Cleared
121d
Avg days
1979
Since
FDA 510(k) Cleared Tube, Aspirating, Bronchoscope, Rigid Devices (Product Code KTR)
4 devices
Cleared
Jul 30, 1993
BAL CATH
Ballard Medical Products
Ear, Nose, Throat
380d
Cleared
Aug 25, 1982
RIGID SUCTION TIPS
Kelleher Corp.
Ear, Nose, Throat
27d
Cleared
Apr 09, 1982
ARGYLE DELEE SUCTION CATHETER W/MUCOUS
Sherwood Medical Co.
Ear, Nose, Throat
38d
Cleared
Aug 22, 1979
ARGYLE TAUSSIG CULTURE CATHETER
Sherwood Medical Co.
Ear, Nose, Throat
37d