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)

THERMODILUTION CATHETER

K-Number: K840992 · 1984-05-23

ApplicantGould, Inc.
Decision Date1984-05-23
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K840992. 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 THERMODILUTION CATHETER?

THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Gould, Inc.. The 510(k) number is K840992.

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

THERMODILUTION CATHETER received FDA 510(k) clearance on 1984-05-23, under 510(k) number K840992.

Who is the listed applicant for THERMODILUTION CATHETER?

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

What is the FDA product code for THERMODILUTION CATHETER?

The FDA product code for THERMODILUTION 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.

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 Gould, Inc. 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

View all 31 devices →

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.

↑