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)

ARTERIAL EMBOLECTOMY CATHETER

K-Number: K900311 · 1990-07-17

ApplicantImpra, Inc.
Decision Date1990-07-17
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K900311. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTERIAL EMBOLECTOMY CATHETER?

ARTERIAL EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Impra, Inc.. The 510(k) number is K900311.

When did ARTERIAL EMBOLECTOMY CATHETER receive FDA 510(k) clearance?

ARTERIAL EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1990-07-17, under 510(k) number K900311.

Who is the listed applicant for ARTERIAL EMBOLECTOMY CATHETER?

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

What is the FDA product code for ARTERIAL EMBOLECTOMY CATHETER?

The FDA product code for ARTERIAL EMBOLECTOMY CATHETER is DXE.

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 Impra, 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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSK004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSK991027BI-DIRECTIONAL TUNNELERK983769DISTAFLO BYPASS GRAFTK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFT

View all 29 devices →

Related Devices (Code: DXE)

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.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK213771Merlin Aspiration SystemMivi Neurovascular, 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.

↑