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FDA 510(k)

BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE

K-Number: K862937 · 1986-09-24

ApplicantVersaflex Delivery Systems, Inc.
Decision Date1986-09-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Versaflex Delivery Systems, Inc.. It received FDA 510(k) clearance on 1986-09-24 under 510(k) number K862937. 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 BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE?

BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1986-09-24. The listed applicant is Versaflex Delivery Systems, Inc.. The 510(k) number is K862937.

When did BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE receive FDA 510(k) clearance?

BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE received FDA 510(k) clearance on 1986-09-24, under 510(k) number K862937.

Who is the listed applicant for BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE?

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

What is the FDA product code for BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE?

The FDA product code for BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE 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 Versaflex Delivery Systems, 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.

K863922VERSAFLEX(TM) DELTA ST(TM) MONITOR

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

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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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