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FDA 510(k)

FLOW DIRECTED THERMODILUTION CATH W/VEN

K-Number: K843412 · 1984-11-20

ApplicantAndover Medical, Inc.
Decision Date1984-11-20
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW DIRECTED THERMODILUTION CATH W/VEN is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1984-11-20 under 510(k) number K843412. 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 CATH W/VEN?

FLOW DIRECTED THERMODILUTION CATH W/VEN is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Andover Medical, Inc.. The 510(k) number is K843412.

When did FLOW DIRECTED THERMODILUTION CATH W/VEN receive FDA 510(k) clearance?

FLOW DIRECTED THERMODILUTION CATH W/VEN received FDA 510(k) clearance on 1984-11-20, under 510(k) number K843412.

Who is the listed applicant for FLOW DIRECTED THERMODILUTION CATH W/VEN?

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

What is the FDA product code for FLOW DIRECTED THERMODILUTION CATH W/VEN?

The FDA product code for FLOW DIRECTED THERMODILUTION CATH W/VEN is KRB.

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Other records listing Andover Medical, Inc. as applicant

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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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