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FDA 510(k)

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM

K-Number: K962858 · 1996-09-30

ApplicantHeartport, Inc.
Decision Date1996-09-30
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1996-09-30 under 510(k) number K962858. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM?

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-30. The listed applicant is Heartport, Inc.. The 510(k) number is K962858.

When did HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM receive FDA 510(k) clearance?

HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM received FDA 510(k) clearance on 1996-09-30, under 510(k) number K962858.

Who is the listed applicant for HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM?

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 ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM?

The FDA product code for HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM is DXC.

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.

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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

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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