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FDA 510(k)

GUIDEWIRE

K-Number: K890959 · 1989-09-12

ApplicantGuidewire Technologies, Inc.
Decision Date1989-09-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Guidewire Technologies, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K890959. 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 GUIDEWIRE?

GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Guidewire Technologies, Inc.. The 510(k) number is K890959.

When did GUIDEWIRE receive FDA 510(k) clearance?

GUIDEWIRE received FDA 510(k) clearance on 1989-09-12, under 510(k) number K890959.

Who is the listed applicant for GUIDEWIRE?

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

What is the FDA product code for GUIDEWIRE?

The FDA product code for 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 Guidewire Technologies, 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.

K902153TEFLON COATED GUIDEWIREK902152MOVABLE CORE GUIDEWIRE

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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