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. and Kelleher Corp..
4
Total
4
Cleared
121d
Avg days
1979
Since
FDA 510(k) Cleared Tube, Aspirating, Bronchoscope, Rigid Devices (Product Code KTR)
4 devices
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