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510(k) K931729

I.V. START KIT by Carapace, Inc. — Product Code FOZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
February 22, 1994
Date Received
April 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

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