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FDA 510(k)

EMBOLECTOMY CATHETER

K-Number: K902327 · 1991-02-25

ApplicantClincal Instruments Corp.
Decision Date1991-02-25
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 Clincal Instruments Corp.. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K902327. 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 1991-02-25. The listed applicant is Clincal Instruments Corp.. The 510(k) number is K902327.

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

EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1991-02-25, under 510(k) number K902327.

Who is the listed applicant for EMBOLECTOMY CATHETER?

The FDA 510(k) record lists Clincal Instruments Corp. 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.

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Other records listing Clincal Instruments Corp. 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.

K860743CAROTID BYPASS SHUNT WITH SAMPLING ARMK860742CAROTID BYPASS SHUNTK852704TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIATK844918OCCLUSION & OCCLUSION-IRRIGATIONK821220MULTILUMEN INTRAVENOUS INFUSION CATHETERK790034INTRODUCERS

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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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