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KTR — Tube, Aspirating, Bronchoscope, Rigid Class II

FDA Device Classification

Classification Details

Product Code
KTR
Device Class
Class II
Regulation Number
874.4680
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K923487ballard medical productsBAL CATHJuly 30, 1993
K822255kelleherRIGID SUCTION TIPSAugust 25, 1982
K820572sherwood medicalARGYLE DELEE SUCTION CATHETER W/MUCOUSApril 9, 1982
K791327sherwood medicalARGYLE TAUSSIG CULTURE CATHETERAugust 22, 1979