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510(k) K940127

CENTERMARK SECURING WINGS by Menlo Care, Inc. — Product Code KMK

K940127 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "CENTERMARK SECURING WINGS". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
January 10, 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 Menlo Care, Inc.

  • K964447 — PICC CATHETER/MIDLINE CATHETER (April 16, 1997)
  • K951620 — MIDMARK MIDLINE CATHETER (April 4, 1996)
  • K945521 — CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (April 6, 1995)
  • K950737 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K944968 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K943893 — PERCUTANEOUS GRAINAGE CATHETER (March 7, 1995)
  • K943143 — BILIARY STENT (February 28, 1995)
  • K930048 — SAFE-PICC CATHETER (May 12, 1994)
  • K933941 — MENLO CARE URINARY DIVERSION STENT (March 31, 1994)
  • K923394 — MENLO CARE AQUASTENT SET (November 16, 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)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (July 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C 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