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)

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING

K-Number: K891013 · 1989-08-02

ApplicantMedtronic Vascular
Decision Date1989-08-02
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1989-08-02 under 510(k) number K891013. The device is classified under product code CCC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING?

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING is a medical device that received FDA 510(k) clearance on 1989-08-02. The listed applicant is Medtronic Vascular. The 510(k) number is K891013.

When did MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING receive FDA 510(k) clearance?

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING received FDA 510(k) clearance on 1989-08-02, under 510(k) number K891013.

Who is the listed applicant for MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING?

The FDA product code for MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING is CCC.

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 Medtronic Vascular 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.

K232570Steerant™ Super Stiff GuidewireK2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterK2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding CatheterK173515Admiral Xtreme

View all 474 devices →

Related Devices (Code: CCC)

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.

K071165ISCALERT SENSOR SYSTEMAlertis Medical ASK983198TRENDCARE CALIBRATOR MODEL SCU 7007Diametrics Medical, Ltd.K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, 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.

↑