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510(k) K924369

ILS(TM) - INVASIVE LINE SEPARATOR by 2-Rn Corp. — Product Code KMK

K924369 is an FDA 510(k) premarket notification submitted by 2-Rn Corp. for the device "ILS(TM) - INVASIVE LINE SEPARATOR". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
August 28, 1992
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

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  • 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)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (July 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)

FDA data resources