SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.— 510(k) K885235

Clearance details

Applicant

Spectramed, Inc.

Product code

Code DSK

Device class

Class 2

Regulation

21 CFR 870.1110

Advisory panel

Cardiovascular

Date received

1988-12-20

Decision date

1989-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oxnard, CA, US

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• Z-1946-2012 — Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.Class II·Terminated·Argon Medical Devices, Inc·20120504

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K885235.