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FDA 510(k)

HEARTPORT ENDOSINUS CATHETER

K-Number: K961270 · 1996-06-18

ApplicantHeartport, Inc.
Decision Date1996-06-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT ENDOSINUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1996-06-18 under 510(k) number K961270. 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 HEARTPORT ENDOSINUS CATHETER?

HEARTPORT ENDOSINUS CATHETER is a medical device that received FDA 510(k) clearance on 1996-06-18. The listed applicant is Heartport, Inc.. The 510(k) number is K961270.

When did HEARTPORT ENDOSINUS CATHETER receive FDA 510(k) clearance?

HEARTPORT ENDOSINUS CATHETER received FDA 510(k) clearance on 1996-06-18, under 510(k) number K961270.

Who is the listed applicant for HEARTPORT ENDOSINUS CATHETER?

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

What is the FDA product code for HEARTPORT ENDOSINUS CATHETER?

The FDA product code for HEARTPORT ENDOSINUS CATHETER 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 Heartport, 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.

K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPK981995QUICKDRAW VENOUS CANNULAK990772DIRECTFLOW ARTERIAL CANNULAK981009HEARTPORT ENDOPULMONARY VENT CATHETERK974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERK974175HEARTPORT ENDOAORTIC CLAMP CATHETER

View all 24 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.

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