Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXTRACORPOREAL BLOOD GAS SYSTEM

K-Number: K822000 · 1982-12-22

ApplicantCardiovascular Devices, Inc.
Decision Date1982-12-22
Product CodeDTY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL BLOOD GAS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Devices, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K822000. The device is classified under product code DTY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL BLOOD GAS SYSTEM?

EXTRACORPOREAL BLOOD GAS SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Cardiovascular Devices, Inc.. The 510(k) number is K822000.

When did EXTRACORPOREAL BLOOD GAS SYSTEM receive FDA 510(k) clearance?

EXTRACORPOREAL BLOOD GAS SYSTEM received FDA 510(k) clearance on 1982-12-22, under 510(k) number K822000.

Who is the listed applicant for EXTRACORPOREAL BLOOD GAS SYSTEM?

The FDA 510(k) record lists Cardiovascular Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRACORPOREAL BLOOD GAS SYSTEM?

The FDA product code for EXTRACORPOREAL BLOOD GAS SYSTEM is DTY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiovascular Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890113THE CDI(R) SYSTEM 400K884228CDI(R) 2000 BLOOD GAS MONITORK871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMK843912INTRAVASCULAR BLOOD GAS SYSTEMK840749GAST STAT MONITORING SYSTEM

View all 8 devices →

Related Devices (Code: DTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMMedtronic Bio-Medicus, Inc.K902654CDI (TM) SYSTEM 100 MONITORING SYSTEM3M Health Care, Ltd.K900860PERFUSION MONITORCardio Metrics, Inc.K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMCardiovascular Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑