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FDA 510(k)

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER

K-Number: K900317 · 1990-06-22

ApplicantElecath
Decision Date1990-06-22
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Elecath. It received FDA 510(k) clearance on 1990-06-22 under 510(k) number K900317. 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 PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER?

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Elecath. The 510(k) number is K900317.

When did PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER receive FDA 510(k) clearance?

PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER received FDA 510(k) clearance on 1990-06-22, under 510(k) number K900317.

Who is the listed applicant for PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER?

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

What is the FDA product code for PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER?

The FDA product code for PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER is KRB.

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.

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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

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

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