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510(k) K932757

SECURODRIP (TM) I.V. ARMBOARD by Op-Co Medical Products , Ltd. — Product Code KMK

K932757 is an FDA 510(k) premarket notification submitted by Op-Co Medical Products , Ltd. for the device "SECURODRIP (TM) I.V. ARMBOARD". The FDA issued a decision of Substantially Equivalent on December 8, 1993. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Op-Co Medical Products , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1993
Date Received
June 4, 1993
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 Op-Co Medical Products , Ltd.

  • K941098 — SECURE-SITE (August 9, 1995)
  • K912660 — SECURODRIP (December 4, 1991)

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