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510(k) K791886

I.V. CARE KIT by Ascep, Inc. — Product Code KGX

K791886 is an FDA 510(k) premarket notification submitted by Ascep, Inc. for the device "I.V. CARE KIT". The FDA issued a decision of Substantially Equivalent on Oct 26, 1979. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Ascep, Inc. has 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 26, 1979
Date Received
Sep 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type
510(k) Exempt

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (Apr 12, 1983)
  • K822893 — G.E.V. DISPOSABLE SCALPELS (Oct 22, 1982)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (Jan 26, 1981)
  • K802726 — INSTRUMENTS NONSTERILE & STERILE (Nov 19, 1980)
  • K791885 — I.V. START SET (Oct 22, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (Oct 17, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (Oct 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (Oct 17, 1979)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (Jun 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (Feb 17, 1999)
  • K972914 — SYVEK PATCH (Dec 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (Jan 17, 1996)
  • K952606 — TARGETT PATCH (Dec 21, 1995)
  • K954007 — PARALLEL (Nov 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (Oct 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (Nov 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (Oct 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (Oct 3, 1994)

FDA data resources

Source: FDA 510(k) database entry for K791886. Report a data issue: hello@regdatalab.com.