Cleared Traditional

K133157 - TRI-OPTIC MEASUREMENT CELL (FDA 510(k) Clearance)

Also includes:
WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6
K133157 · Medtronic, Inc. · Cardiovascular device
Oct 2014
Decision
371d
Days
Class 2
Risk

K133157 is an FDA 510(k) clearance for the TRI-OPTIC MEASUREMENT CELL. This device is classified as a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DRY).

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 23, 2014, 371 days after receiving the submission on October 17, 2013.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K133157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date October 23, 2014
Days to Decision 371 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.4330