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FDA 510(k)

FLOW-DIRECTED THERMODILUTION CATHETER

K-Number: K812800 · 1981-10-20

ApplicantSorensen Research
Decision Date1981-10-20
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW-DIRECTED THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1981-10-20 under 510(k) number K812800. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-DIRECTED THERMODILUTION CATHETER?

FLOW-DIRECTED THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1981-10-20. The listed applicant is Sorensen Research. The 510(k) number is K812800.

When did FLOW-DIRECTED THERMODILUTION CATHETER receive FDA 510(k) clearance?

FLOW-DIRECTED THERMODILUTION CATHETER received FDA 510(k) clearance on 1981-10-20, under 510(k) number K812800.

Who is the listed applicant for FLOW-DIRECTED THERMODILUTION CATHETER?

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

What is the FDA product code for FLOW-DIRECTED THERMODILUTION CATHETER?

The FDA product code for FLOW-DIRECTED THERMODILUTION CATHETER is KRB.

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Other records listing Sorensen Research 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.

K833674ACCURATE MEASUREMENT DEVICE KG-AMDK833673ACCURATE MEASUREMENT DEVICE EZ-AMDK833095TRANSDUCER DOME SD105K833096TRANSDUCER DOME DS106K833094TRANSDUCER DOME SD104K832957FLOW-DIRECTED HEPARIN COATED THERMODIL

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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.

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