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FDA 510(k)

FOGARTY ARTERIAL EMBOLECTOMY II CATHETER

K-Number: K901625 · 1990-07-06

ApplicantBaxter Healthcare Corp
Decision Date1990-07-06
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY ARTERIAL EMBOLECTOMY II CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-07-06 under 510(k) number K901625. 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 FOGARTY ARTERIAL EMBOLECTOMY II CATHETER?

FOGARTY ARTERIAL EMBOLECTOMY II CATHETER is a medical device that received FDA 510(k) clearance on 1990-07-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K901625.

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

FOGARTY ARTERIAL EMBOLECTOMY II CATHETER received FDA 510(k) clearance on 1990-07-06, under 510(k) number K901625.

Who is the listed applicant for FOGARTY ARTERIAL EMBOLECTOMY II CATHETER?

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

What is the FDA product code for FOGARTY ARTERIAL EMBOLECTOMY II CATHETER?

The FDA product code for FOGARTY ARTERIAL EMBOLECTOMY II CATHETER is DXE.

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Other records listing Baxter Healthcare Corp as applicant

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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.

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