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510(k) K083081

Device
MODIFICATION TO SECURACATH, MODEL: SPK01
Applicant
INTERRAD MEDICAL, INC.
510(k) number
K083081
Product code
OKC  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-04
Date received
2008-10-16
Regulation
880.5970
Classification name
Implanted Subcutaneous Securement Catheter
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sew-Wah Tay
Address
18555 37th Ave. N. Plymouth MN US 55446 55446

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OKC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210629SecurAcathInterrad Medical, Inc.2021-04-12
K180769SecurAcathInterrad Medical, Inc.2018-06-26
K120935SECURACATHInterrad Medical, Inc.2012-04-27
K082047SECURACATH CATHETER, MODEL SPK01Interrad Medical, Inc.2008-09-30

Legacy Summary#

summary

FDA Review#

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