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510(k) K861563

VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT by Vitaphore Corp. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1986
Date Received
April 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
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)
  • K896046 — VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE (January 11, 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)

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