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FDA 510(k)

Steerant™ Super Stiff Guidewire

K-Number: K232570 · 2023-10-24

ApplicantMedtronic Vascular
Decision Date2023-10-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Steerant™ Super Stiff Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232570. 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 Steerant™ Super Stiff Guidewire?

Steerant™ Super Stiff Guidewire is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Medtronic Vascular. The 510(k) number is K232570.

When did Steerant™ Super Stiff Guidewire receive FDA 510(k) clearance?

Steerant™ Super Stiff Guidewire received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232570.

Who is the listed applicant for Steerant™ Super Stiff Guidewire?

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

What is the FDA product code for Steerant™ Super Stiff Guidewire?

The FDA product code for Steerant™ Super Stiff 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.

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Other records listing Medtronic Vascular 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.

PMA P160043Coronary drug-eluting stentPMA P110023STENT, SUPERFICIAL FEMORAL ARTERYPMA P060001Stent, carotidPMA P190008Drug-coated peripheral transluminal angioplasty catheterPMA P100021SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTPMA P200026Stent, iliac vein

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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.

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.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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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