FDA.reportPublic FDA data

510(k) K803037

Device
William Harvey Vented Mediastinal Drain
Applicant
C.R. BARD, INC.
510(k) number
K803037
Product code
DWM
Decision
Substantially Equivalent (SESE)
Decision date
1981-02-04
Date received
1980-12-01
Regulation
870.5050
Classification name
Apparatus, Suction, Patient Care
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K112831PLEURX PLEURAL CATHETER SYSTEMSCare Fusion2012-02-16
K110409ASPIRA PLEURAL DRAINAGE SYSTEMC.R. Bard, Inc.2011-05-11
K093307ASEPT PLEURAL DRAINAGE SYSTEMPfm Medical, Inc.2009-11-06
K071095ASPIRA PLEURAL DRAINAGE SYSTEMBard Access Systems, Inc.2007-05-18
K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000Denver Biomedical, Inc.2005-10-06
K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEDenver Biomedicals, Inc.2005-06-13