Medtronic Intravascular Blood Gas Monitoring
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K891013 FDA 510(k)
- FDA Product Code
- CCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1150 FDA 510(k)
- Regulation Number
- 868.1150 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Intravascular Blood Gas Monitoring is an indwelling blood carbon dioxide partial pressure PCO2 analyzer that consists of a catheter-tip PCO2 transducer. It is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
This device is supplied by Medtronic Vascular and is classified as an Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling with product code CCC. It is a Class II device under Special Controls and received FDA 510(k) clearance on August 2, 1989, with K number K891013.
Frequently asked questions
What is the Medtronic Intravascular Blood Gas Monitoring used for?
It is used to measure, in vivo, the partial pressure of carbon dioxide (PCO2) in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status. This helps clinicians assess respiratory and metabolic function during critical care or surgical procedures.
How is the Medtronic Intravascular Blood Gas Monitoring supplied and is it reusable?
The device is supplied by Medtronic Vascular as an indwelling blood gas analyzer with a catheter-tip PCO2 transducer. It is designed for single-use only and is not intended for reuse, reprocessing, or resterilization due to the risk of contamination and potential compromise of measurement accuracy.
What regulatory pathway was used for the Medtronic Intravascular Blood Gas Monitoring?
The device received FDA 510(k) clearance on August 2, 1989, under K number K891013, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II device under Special Controls with product code CCC.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K891013 - MEDTRONIC INTRAVASCULAR BLOOD GAS MONIT... | FDA 510(k), MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING (K891013) — FDA 510 (k ..., PDF Perfusion systems and blood management - Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K891013 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K891013 24 fields · synced Oct 6, 2026