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510(k) K982945

Device
DUAL PURPOSE CLOSED CATHETER
Applicant
SPIRIT MEDICAL SYSTEMS, INC.
510(k) number
K982945
Product code
BSY  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-22
Date received
1998-08-21
Regulation
868.6810
Classification name
Catheters, Suction, Tracheobronchial
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFF SAWYER
Address
16267 Whitestone Dr. Parker CO US 80134 80134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BSY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.2003-11-25
K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.1999-10-25
K981910SUCTION CATHETERNi-Med, Inc.1998-08-24
K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt Medical1997-12-29
K973199AMSINO SUCTION CATHETERAmsino Intl., Inc.1997-09-10
K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care1997-03-11
K964369TRACH CARE SET WITH MICROBANBallard Medical Products1997-02-11
K960488NEO 2 LINE SUCTION SYSTEMAlcove Medical, Inc.1996-04-26
K955831ARGYLE ASPR-CARE CLOSED SUCTION SYSTEMSherwood Medical Co.1996-03-28
K955645CATH-GUIDEHudson Respiratory Care, Inc.1996-03-12
K952396REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIONContour Fabricators of Florida, Inc.1995-08-15
K952395REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATIONContour Fabricators of Florida, Inc.1995-08-15
K953226PULM O2 SUCTION CATHETER TRAYSPremium Plastics, Inc.1995-08-08
K951506SUCTION CATHETER KIT, STERILE, SINGLE-USETrinity Laboratories, Inc.1995-07-03
K945994DUAL PURPOSE CATHETERUniversal Medical Products, Inc.1995-06-21

Legacy Summary#

summary

FDA Review#

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