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510(k) K896046

VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE by Vitaphore Corp. — Product Code KMK

K896046 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Vitaphore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
October 17, 1989
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 Vitaphore Corp.

  • K914579 — SILVER FOAM WOUND DRESSING (February 21, 1992)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K895920 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (June 6, 1991)
  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • K891993 — COLLAGEN NEUROSPONGE (March 23, 1990)
  • K896455 — VITACHOICE WOUND DRESSING (February 15, 1990)
  • K895993 — VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (January 11, 1990)
  • K890435 — VITAACCESS CATHETER INTRODUCER KIT (March 29, 1989)
  • K882100 — VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT (July 13, 1988)
  • K872998 — VITAACCESS (TM) CATHETER INTRODUCER SYSTEM (March 24, 1988)

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