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FDA 510(k)

EMBO PLUS EMBOLECTOMY CATHETER

K-Number: K100840 · 2010-07-12

ApplicantHotspur Technologies
Decision Date2010-07-12
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBO PLUS EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hotspur Technologies. It received FDA 510(k) clearance on 2010-07-12 under 510(k) number K100840. 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 EMBO PLUS EMBOLECTOMY CATHETER?

EMBO PLUS EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 2010-07-12. The listed applicant is Hotspur Technologies. The 510(k) number is K100840.

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

EMBO PLUS EMBOLECTOMY CATHETER received FDA 510(k) clearance on 2010-07-12, under 510(k) number K100840.

Who is the listed applicant for EMBO PLUS EMBOLECTOMY CATHETER?

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

What is the FDA product code for EMBO PLUS EMBOLECTOMY CATHETER?

The FDA product code for EMBO PLUS EMBOLECTOMY CATHETER is DXE.

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Other records listing Hotspur Technologies 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.

K130397ARROW GPSCATH BALLOON DILATATION CATHETERK113769GPSCATH BALLON DILATATION CATHETERK101047PTA-DUO PTA BALLOON CATHETERK100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

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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