K821056Substantially Equivalent

Flow Directed Thermal-Dilution Catheter

Name: K821056 Flow Directed Thermal-Dilution Catheter
Creator: Oximetrix, Inc.
Published: 1982-05-18
License: https://open.fda.gov/license/

Oximetrix, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K821056 is the FDA 510(k) clearance record for FLOW DIRECTED THERMAL-DILUTION CATHETER, cleared for Oximetrix, Inc. on 1982-05-18. FDA records list 12 510(k) clearances for Oximetrix, Inc., from 1976-08-23 to 1986-01-13. As of 2026-09-10, FDA records show no recalls naming K821056.

Clearance record

Decision date: 1982-05-18
Received: 1982-04-15 (33 days to decision)
Review panel: Unknown
Applicant: Oximetrix, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No