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510(k) K931873

VACVENT by Steven Frank Mercereau — Product Code CBT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 30, 1993
Date Received
April 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arterial Blood Sampling Kit
Device Class
Class I
Regulation Number
868.1100
Review Panel
AN
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K950098 — NEEDLE SAFETY COVER (August 11, 1995)
  • K945719 — ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (March 16, 1995)
  • K944941 — PISTON SYRINGE (December 5, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K940575 — ASPIR-PULSE(TM) SAF-T-VENT (March 22, 1994)