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510(k) K943147

STATLOCK CV by Venetec, Inc. — Product Code KMK

K943147 is an FDA 510(k) premarket notification submitted by Venetec, Inc. for the device "STATLOCK CV". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Venetec, Inc. has at least 3 other 510(k) clearances on record.

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

  • 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)
  • 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)

FDA data resources