FDA.reportPublic FDA data

510(k) K082047

Device
SECURACATH CATHETER, MODEL SPK01
Applicant
INTERRAD MEDICAL, INC.
510(k) number
K082047
Product code
OKC  
Decision
Substantially Equivalent (SESE)
Decision date
2008-09-30
Date received
2008-07-18
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
K083081MODIFICATION TO SECURACATH, MODEL: SPK01Interrad Medical, Inc.2009-03-04

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases