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FDA 510(k)

HEART TECHNOLOGY WIRECLIP

K-Number: K914581 · 1992-01-06

ApplicantHeart Technology, Inc.
Decision Date1992-01-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART TECHNOLOGY 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 1992-01-06 under 510(k) number K914581. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART TECHNOLOGY WIRECLIP?

HEART TECHNOLOGY WIRECLIP is a medical device that received FDA 510(k) clearance on 1992-01-06. The listed applicant is Heart Technology, Inc.. The 510(k) number is K914581.

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

HEART TECHNOLOGY WIRECLIP received FDA 510(k) clearance on 1992-01-06, under 510(k) number K914581.

Who is the listed applicant for HEART TECHNOLOGY 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 WIRECLIP?

The FDA product code for HEART TECHNOLOGY WIRECLIP is DQX.

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, MODIFICATIONK913450HEART TECHNOLOGY ROTABLATOR WIRECLIPK901206ROTABLATOR

Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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