FDA 510(k) Applications for Medical Device Product Code "BSY"
(Catheters, Suction, Tracheobronchial)

FDA 510(k) Number Applicant Device Name Decision Date
K960488 ALCOVE MEDICAL, INC. NEO 2 LINE SUCTION SYSTEM 04/26/1996
K992902 AMBU, INC. AMBU HAND POWER SUCTION PUMP 10/25/1999
K973199 AMSINO INTL., INC. AMSINO SUCTION CATHETER 09/10/1997
K964369 BALLARD MEDICAL PRODUCTS TRACH CARE SET WITH MICROBAN 02/11/1997
K955645 HUDSON RESPIRATORY CARE, INC. CATH-GUIDE 03/12/1996
K031997 MALLINCKRODT DAR S.R.L. MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM 11/25/2003
K972258 MALLINCKRODT MEDICAL HI-CARE CLOSED SUCTION SYSTEM 12/29/1997
K981910 NI-MED, INC. SUCTION CATHETER 08/24/1998
K955831 SHERWOOD MEDICAL CO. ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM 03/28/1996
K961707 SORENSON CRITICAL CARE TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM 03/11/1997
K982945 SPIRIT MEDICAL SYSTEMS, INC. DUAL PURPOSE CLOSED CATHETER 09/22/1998


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