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)

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM

K-Number: K082321 · 2009-02-13

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2009-02-13
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K082321. 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 TERUMO ROCSAFE HYBRID PERFUSION SYSTEM?

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K082321.

When did TERUMO ROCSAFE HYBRID PERFUSION SYSTEM receive FDA 510(k) clearance?

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM received FDA 510(k) clearance on 2009-02-13, under 510(k) number K082321.

Who is the listed applicant for TERUMO ROCSAFE HYBRID PERFUSION SYSTEM?

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

What is the FDA product code for TERUMO ROCSAFE HYBRID PERFUSION SYSTEM?

The FDA product code for TERUMO ROCSAFE HYBRID PERFUSION SYSTEM 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 Corp. 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.

K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRK130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHAK123039CDI BLOOD PARAMETER MONITORING SYSTEM 500K113214TLINK DATA MANAGEMENT SYSTEM (DMS)K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

View all 38 devices →

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.

↑