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FDA 510(k)

SARN CENTRIFUGAL PUMP

K-Number: K112229 · 2011-12-09

ApplicantTerumo Cardiovascular Systems
Decision Date2011-12-09
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARN CENTRIFUGAL PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems. It received FDA 510(k) clearance on 2011-12-09 under 510(k) number K112229. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARN CENTRIFUGAL PUMP?

SARN CENTRIFUGAL PUMP is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Terumo Cardiovascular Systems. The 510(k) number is K112229.

When did SARN CENTRIFUGAL PUMP receive FDA 510(k) clearance?

SARN CENTRIFUGAL PUMP received FDA 510(k) clearance on 2011-12-09, under 510(k) number K112229.

Who is the listed applicant for SARN CENTRIFUGAL PUMP?

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

What is the FDA product code for SARN CENTRIFUGAL PUMP?

The FDA product code for SARN CENTRIFUGAL PUMP is KFM.

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 Terumo Cardiovascular Systems 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.

K090698CAPIOX BUBBLE TRAP WITH X-COATING

Related Devices (Code: KFM)

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.

K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.LK232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.LK200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation

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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