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510(k) K854040

I.V. DRESSING by Consolidated Medical Equipment, Inc. — Product Code KMK

K854040 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "I.V. DRESSING". The FDA issued a decision of Substantially Equivalent on Jan 9, 1986. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Consolidated Medical Equipment, Inc. has 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 9, 1986
Date Received
Oct 2, 1985
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
510(k) Exempt

Other clearances by Consolidated Medical Equipment, Inc.

  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (Apr 9, 1985)
  • K850130 — PRN ECG ELECTRODE (Apr 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (Mar 19, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (Mar 12, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (Mar 5, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (Mar 5, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (Feb 28, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (Feb 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (Feb 21, 1985)
  • K844371 — HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE (Feb 20, 1985)

Other clearances for product code KMK

  • K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F… (Jul 9, 2019)
  • K981860 — A P HARNESS (Jun 3, 1999)
  • K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER (Oct 11, 1996)
  • K941098 — SECURE-SITE (Aug 9, 1995)
  • K943147 — STATLOCK CV (Sep 29, 1994)
  • K943047 — IV START KITS (Sep 14, 1994)
  • K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE (Jul 14, 1994)
  • K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (Jul 14, 1994)
  • K935389 — CONMED VENI-GARD I.V. DRESSING (Mar 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (Feb 18, 1994)

FDA data resources

Source: FDA 510(k) database entry for K854040. Report a data issue: hello@regdatalab.com.