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510(k) K120935

SECURACATH by Interrad Medical, Inc. — Product Code OKC

K120935 is an FDA 510(k) premarket notification submitted by Interrad Medical, Inc. for the device "SECURACATH". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code OKC (Implanted Subcutaneous Securement Catheter), a Class II device regulated under 21 CFR 880.5970. Interrad Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
March 28, 2012
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.

  • K210629 — SecurAcath (April 12, 2021)
  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • K180769 — SecurAcath (June 26, 2018)
  • 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

  • K210629 — SecurAcath (April 12, 2021)
  • K180769 — SecurAcath (June 26, 2018)
  • K083081 — MODIFICATION TO SECURACATH, MODEL: SPK01 (March 4, 2009)
  • K082047 — SECURACATH CATHETER, MODEL SPK01 (September 30, 2008)

FDA data resources