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FDA 510(k)

HEARTPORT MULTIFIRE CLIP APPLIER

K-Number: K961333 · 1996-11-15

ApplicantHeartport, Inc.
Decision Date1996-11-15
Product CodeDSS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT MULTIFIRE CLIP APPLIER is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K961333. The device is classified under product code DSS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTPORT MULTIFIRE CLIP APPLIER?

HEARTPORT MULTIFIRE CLIP APPLIER is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Heartport, Inc.. The 510(k) number is K961333.

When did HEARTPORT MULTIFIRE CLIP APPLIER receive FDA 510(k) clearance?

HEARTPORT MULTIFIRE CLIP APPLIER received FDA 510(k) clearance on 1996-11-15, under 510(k) number K961333.

Who is the listed applicant for HEARTPORT MULTIFIRE CLIP APPLIER?

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 MULTIFIRE CLIP APPLIER?

The FDA product code for HEARTPORT MULTIFIRE CLIP APPLIER is DSS.

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: DSS)

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.

K983744MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical ResourcesK920104IDENTI LOOPS DEGANIA SILICONEPuritas Health Care, Inc.K920676RMI SOFCLAMPResearch Medical, Inc.K914523CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILCatheter Research C/O Burditt, Bowles & RadziusK901303HORIZON SURGICAL LIGATING AND MARKING CLIPHorizon Surgical, Inc.K883909SURGICAL SPRING CLIPSApplied Vascular Devices, 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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