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510(k) K180994

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F by Interrad Medical, Inc. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2019
Date Received
April 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Interrad Medical, Inc.

  • K210629 — SecurAcath (April 12, 2021)
  • 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 KMK

  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • K943147 — STATLOCK CV (September 29, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)