510(k) K955663

ABC IN-LINE BLOOD SAMPLING KIT by Utah Medical Products, Inc. — Product Code CBT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 17, 1997
Date Received: December 13, 1995
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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K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
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K965245 — TBD (July 3, 1997)
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K961424 — INTRAN 500 (July 10, 1996)

Other clearances for product code CBT

K071269 — HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (August 1, 2007)
K070340 — SECURE ARTERIAL BLOOD SAMPLING SYSTEM (March 15, 2007)
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)
K931873 — VACVENT (December 30, 1993)