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FDA 510(k)

ARTERIAL EMBOLECTOMY

K-Number: K935405 · 1994-07-25

ApplicantJ-Lloyd Medical, Inc.
Decision Date1994-07-25
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL EMBOLECTOMY is the device name listed in this FDA 510(k) record. The listed applicant is J-Lloyd Medical, Inc.. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K935405. 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 ARTERIAL EMBOLECTOMY?

ARTERIAL EMBOLECTOMY is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K935405.

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

ARTERIAL EMBOLECTOMY received FDA 510(k) clearance on 1994-07-25, under 510(k) number K935405.

Who is the listed applicant for ARTERIAL EMBOLECTOMY?

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

What is the FDA product code for ARTERIAL EMBOLECTOMY?

The FDA product code for ARTERIAL EMBOLECTOMY is DXE.

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Other records listing J-Lloyd Medical, 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.

K971504HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETERK973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)K950440DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

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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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