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510(k) K943147

STATLOCK CV by Venetec, Inc. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
June 30, 1994
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 Venetec, Inc.

  • K943038 — STATLOCK-IPIDURAL (April 10, 1995)
  • K942931 — STATLOCK SECUREMENT DEVICES (March 28, 1995)
  • K902109 — STATLOCK IV CONNECTOR AND ANCHOR SET (October 19, 1990)

Other clearances for product code KMK

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  • K981860 — A P HARNESS (June 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (October 11, 1996)
  • K941098 — SECURE-SITE (August 9, 1995)
  • 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)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)