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FDA 510(k)

EMBOLECTOMY CATHETER

K-Number: K832023 · 1983-08-31

ApplicantBionomy, Inc.
Decision Date1983-08-31
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bionomy, Inc.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832023. 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 EMBOLECTOMY CATHETER?

EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Bionomy, Inc.. The 510(k) number is K832023.

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

EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832023.

Who is the listed applicant for EMBOLECTOMY CATHETER?

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

What is the FDA product code for EMBOLECTOMY CATHETER?

The FDA product code for 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 Bionomy, 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.

K851101BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SETK844094PRUITT IRRIGATION AND OCCLUSION CATHETERK812111PRUITT ARTERIAL OCCLUSION CHOLANG. CATHK811276OCCLUSION CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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