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BSY — Catheters, Suction, Tracheobronchial Class I

FDA Device Classification

Classification Details

Product Code
BSY
Device Class
Class I
Regulation Number
868.6810
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K031997mallinckrodt darMALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMNovember 25, 2003
K992902ambuAMBU HAND POWER SUCTION PUMPOctober 25, 1999
K982945spirit medical systemsDUAL PURPOSE CLOSED CATHETERSeptember 22, 1998
K981910ni-medSUCTION CATHETERAugust 24, 1998
K972258mallinckrodt medicalHI-CARE CLOSED SUCTION SYSTEMDecember 29, 1997
K973199amsino intlAMSINO SUCTION CATHETERSeptember 10, 1997
K961707sorenson critical careTRACH-EZE CLOSED VENTILATION SUCTION SYSTEMMarch 11, 1997
K964369ballard medical productsTRACH CARE SET WITH MICROBANFebruary 11, 1997
K960488alcove medicalNEO 2 LINE SUCTION SYSTEMApril 26, 1996
K955831sherwood medicalARGYLE ASPR-CARE CLOSED SUCTION SYSTEMMarch 28, 1996
K955645hudson respiratory careCATH-GUIDEMarch 12, 1996
K952395contour fabricators of floridaREDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATIONAugust 15, 1995
K952396contour fabricators of floridaREDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIONAugust 15, 1995
K953226premium plasticsPULM O2 SUCTION CATHETER TRAYSAugust 8, 1995
K951506trinity laboratoriesSUCTION CATHETER KIT, STERILE, SINGLE-USEJuly 3, 1995
K945994universal medical productsDUAL PURPOSE CATHETERJune 21, 1995
K951745vital signsCONNECTING TUBEMay 30, 1995
K945950vital signsTRIGUARD(TM) SUCTION SYSTEMDecember 27, 1994
K944251kendall healthcare products co. div.of tyco healthKENDALL MODU-VAC CLOSED SUCTION SYSTEMSeptember 21, 1994
K935600puritas health careTRACHEAL SUCTION CATHETERMay 10, 1994