Cleared Traditional

K910471 - MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (FDA 510(k) Clearance)

Mar 1991
Decision
32d
Days
Class 2
Risk

K910471 is an FDA 510(k) clearance for the MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE. This device is classified as a Tubing, Noninvasive (Class II - Special Controls, product code GAZ).

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 8, 1991, 32 days after receiving the submission on February 4, 1991.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K910471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date March 08, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6740