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FDA 510(k)

ELECATH ARTERIAL EMBOLECTOMY CATHETER

K-Number: K761031 · 1976-12-13

ApplicantElectro-Catheter Corp.
Decision Date1976-12-13
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH ARTERIAL EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1976-12-13 under 510(k) number K761031. 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 ELECATH ARTERIAL EMBOLECTOMY CATHETER?

ELECATH ARTERIAL EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1976-12-13. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K761031.

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

ELECATH ARTERIAL EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1976-12-13, under 510(k) number K761031.

Who is the listed applicant for ELECATH ARTERIAL EMBOLECTOMY CATHETER?

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

What is the FDA product code for ELECATH ARTERIAL EMBOLECTOMY CATHETER?

The FDA product code for ELECATH ARTERIAL EMBOLECTOMY CATHETER is DXE.

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Other records listing Electro-Catheter 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.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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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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