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)

THREE STAGE VENOUS RETURN CANNULA, MODEL 816460

K-Number: K080034 · 2008-06-17

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2008-06-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 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 2008-06-17 under 510(k) number K080034. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THREE STAGE VENOUS RETURN CANNULA, MODEL 816460?

THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 is a medical device that received FDA 510(k) clearance on 2008-06-17. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K080034.

When did THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 receive FDA 510(k) clearance?

THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 received FDA 510(k) clearance on 2008-06-17, under 510(k) number K080034.

Who is the listed applicant for THREE STAGE VENOUS RETURN CANNULA, MODEL 816460?

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 THREE STAGE VENOUS RETURN CANNULA, MODEL 816460?

The FDA product code for THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 is DWF.

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.

K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHAK130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRK123039CDI 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: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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.

↑