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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
K952396contour fabricators of floridaREDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIONAugust 15, 1995
K952395contour fabricators of floridaREDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATIONAugust 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