510(k) K897133

MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT by Transidyne General Corp. — Product Code CBT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 30, 1990
Date Received: December 27, 1989
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.

Other clearances by Transidyne General Corp.

K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
K955658 — LACERATION TRAY (January 25, 1996)
K950743 — ORAL PROCEDURE PACK (March 31, 1995)
K950773 — PROPHYLAXIS PACK (March 31, 1995)
K950449 — SURGICAL BUR (March 1, 1995)
K950403 — SURGICAL SAW BLADES (February 21, 1995)
K924811 — I.V. START KIT (June 17, 1993)
K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
K922339 — SUTURE REMOVAL KIT (December 11, 1992)
K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)

Other clearances for product code CBT

K071269 — HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (August 1, 2007)
K070340 — SECURE ARTERIAL BLOOD SAMPLING SYSTEM (March 15, 2007)
K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
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)