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510(k) K925502

TRACE MODEL# 840, 841,842 & 845 ARM BOARD by Trace Medical Equipment, Inc. — Product Code KMK

K925502 is an FDA 510(k) premarket notification submitted by Trace Medical Equipment, Inc. for the device "TRACE MODEL# 840, 841,842 & 845 ARM BOARD". The FDA issued a decision of Substantially Equivalent on January 12, 1993. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Trace Medical Equipment, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1993
Date Received
October 30, 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

Other clearances by Trace Medical Equipment, Inc.

  • K925145 — TRACE MODEL #'S 840, 841, 842, 845 (May 19, 1993)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec (July 9, 2019)
  • 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)
  • 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