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)

HEARTPORT ENDOAORTIC CLAMP CATHETER

K-Number: K974175 · 1997-12-16

ApplicantHeartport, Inc.
Decision Date1997-12-16
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTPORT ENDOAORTIC CLAMP 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 1997-12-16 under 510(k) number K974175. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTPORT ENDOAORTIC CLAMP CATHETER?

HEARTPORT ENDOAORTIC CLAMP CATHETER is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Heartport, Inc.. The 510(k) number is K974175.

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

HEARTPORT ENDOAORTIC CLAMP CATHETER received FDA 510(k) clearance on 1997-12-16, under 510(k) number K974175.

Who is the listed applicant for HEARTPORT ENDOAORTIC CLAMP 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 ENDOAORTIC CLAMP CATHETER?

The FDA product code for HEARTPORT ENDOAORTIC CLAMP CATHETER is DWZ.

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 INTRODUCERK972570HEARTPORT INTRODUCER SHEATH

View all 24 devices →

Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK991486ULTRA-CBXMedcanica, 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.

↑