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FDA 510(k)

S-Wire Guidewire System

K-Number: K153397 · 2016-08-18

ApplicantConcert Medical, LLC
Decision Date2016-08-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S-Wire Guidewire System is the device name listed in this FDA 510(k) record. The listed applicant is Concert Medical, LLC. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K153397. 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 S-Wire Guidewire System?

S-Wire Guidewire System is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Concert Medical, LLC. The 510(k) number is K153397.

When did S-Wire Guidewire System receive FDA 510(k) clearance?

S-Wire Guidewire System received FDA 510(k) clearance on 2016-08-18, under 510(k) number K153397.

Who is the listed applicant for S-Wire Guidewire System?

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

What is the FDA product code for S-Wire Guidewire System?

The FDA product code for S-Wire Guidewire System is DQX.

Other records listing Concert Medical, LLC 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.

K153599Concert Medical Hands-Free Syringe (HFS)

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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