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510(k) K210629

SecurAcath by Interrad Medical, Inc. — Product Code OKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2021
Date Received
March 2, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implanted Subcutaneous Securement Catheter
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.

Other clearances by Interrad Medical, Inc.

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K180769 — SecurAcath (June 26, 2018)
  • K120935 — SECURACATH (April 27, 2012)
  • K092306 — SECURACATH UNIVERSAL (July 9, 2010)
  • K083081 — MODIFICATION TO SECURACATH, MODEL: SPK01 (March 4, 2009)
  • K082047 — SECURACATH CATHETER, MODEL SPK01 (September 30, 2008)

Other clearances for product code OKC

  • K180769 — SecurAcath (June 26, 2018)
  • K120935 — SECURACATH (April 27, 2012)
  • K083081 — MODIFICATION TO SECURACATH, MODEL: SPK01 (March 4, 2009)
  • K082047 — SECURACATH CATHETER, MODEL SPK01 (September 30, 2008)