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510(k) K863446

Device
ANGIOMED HIGH PRESSURE CONNECTORS
Applicant
ANGIOMED U.S., INC.
510(k) number
K863446
Product code
GCD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-23
Date received
1986-09-08
Regulation
878.4200
Classification name
Connector, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD P MOHR
Address
4081 E. La Palma Ave., Suite E Anaheim CA US 92807 92807

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952470ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.R-Group Intl.1995-11-28
K940198L-CATH CONNECTOR ASSEMBLYLuther Medical Products, Inc.1994-12-15
K851196INCISION DRAINSil-Med Corp.1985-06-04
K851921Y CONNECTORSil-Med Corp.1985-05-17
K760382CONNECTORSB. Braun Instruments1976-11-02
K760524CATHETER CONNECTOR, ARGYLE TUBINGSherwood Medical Industries1976-11-02
K760203TUBE, STERILE NON-CONDUCTIVE CONNECTINGIpco Corp.1976-07-19

Legacy Summary#

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FDA Review#

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