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FDA 510(k)

HEART TECHNOLOGY ROTABLATOR WIRECLIP

K-Number: K913450 · 1991-09-06

ApplicantHeart Technology, Inc.
Decision Date1991-09-06
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART TECHNOLOGY ROTABLATOR WIRECLIP is the device name listed in this FDA 510(k) record. The listed applicant is Heart Technology, Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K913450. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART TECHNOLOGY ROTABLATOR WIRECLIP?

HEART TECHNOLOGY ROTABLATOR WIRECLIP is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Heart Technology, Inc.. The 510(k) number is K913450.

When did HEART TECHNOLOGY ROTABLATOR WIRECLIP receive FDA 510(k) clearance?

HEART TECHNOLOGY ROTABLATOR WIRECLIP received FDA 510(k) clearance on 1991-09-06, under 510(k) number K913450.

Who is the listed applicant for HEART TECHNOLOGY ROTABLATOR WIRECLIP?

The FDA 510(k) record lists Heart Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART TECHNOLOGY ROTABLATOR WIRECLIP?

The FDA product code for HEART TECHNOLOGY ROTABLATOR WIRECLIP is MCW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Heart Technology, 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.

K933238ROTABLATOR, MODIFICATIONK914581HEART TECHNOLOGY WIRECLIPK901206ROTABLATOR

Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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