Cleared Traditional

K915726 - PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH (FDA 510(k) Clearance)

K915726 · Baxter Healthcare Corp · Cardiovascular device
Sep 1992
Decision
276d
Days
Class 2
Risk

K915726 is an FDA 510(k) clearance for the PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 21, 1992, 276 days after receiving the submission on December 20, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K915726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date September 21, 1992
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1200