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FDA 510(k)

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER

K-Number: K850015 · 1985-06-19

ApplicantPolymed Laboratories
Decision Date1985-06-19
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Polymed Laboratories. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K850015. 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 POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER?

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Polymed Laboratories. The 510(k) number is K850015.

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

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1985-06-19, under 510(k) number K850015.

Who is the listed applicant for POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER?

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

What is the FDA product code for POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER?

The FDA product code for POLYMED LAB 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 Polymed Laboratories 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.

K862124POLYMED LABORATORIES ALL SILICONE FOLEY 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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