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FDA 510(k)

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

K-Number: K100842 · 2010-07-12

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

Device Summary

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM 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 K100842. 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 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM?

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM 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 K100842.

When did PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM receive FDA 510(k) clearance?

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM received FDA 510(k) clearance on 2010-07-12, under 510(k) number K100842.

Who is the listed applicant for PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM?

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 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM?

The FDA product code for PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM is DXE.

Related Clinical Trials

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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 CATHETERK100840EMBO PLUS EMBOLECTOMY CATHETER

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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