Cleared Traditional

MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT

K897133 · Transidyne General Corp. · Anesthesiology

Mar 1990

Decision

93d

Days

Class 1

Risk

About This 510(k) Submission

K897133 is an FDA 510(k) clearance for the MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on March 30, 1990, 93 days after receiving the submission on December 27, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K897133 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1989
Decision Date	March 30, 1990
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	CBT — Arterial Blood Sampling Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 868.1100
Definition	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.