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FDA 510(k)

TFX MEDICAL GUIDEWIRE

K-Number: K963320 · 1996-12-03

ApplicantTfx Medical Group
Decision Date1996-12-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TFX MEDICAL GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Tfx Medical Group. It received FDA 510(k) clearance on 1996-12-03 under 510(k) number K963320. 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 TFX MEDICAL GUIDEWIRE?

TFX MEDICAL GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1996-12-03. The listed applicant is Tfx Medical Group. The 510(k) number is K963320.

When did TFX MEDICAL GUIDEWIRE receive FDA 510(k) clearance?

TFX MEDICAL GUIDEWIRE received FDA 510(k) clearance on 1996-12-03, under 510(k) number K963320.

Who is the listed applicant for TFX MEDICAL GUIDEWIRE?

The FDA 510(k) record lists Tfx Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TFX MEDICAL GUIDEWIRE?

The FDA product code for TFX MEDICAL 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 Tfx Medical Group 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.

K992664TFX MEDICAL STYLET CATHETERK991647TFX MEDICAL INTRODUCER KIT

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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