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510(k) K092306

SECURACATH UNIVERSAL by Interrad Medical, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
July 29, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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

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