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FDA 510(k)

PW Guidewires

K-Number: K152497 · 2016-01-22

ApplicantTatara Vascular, LLC
Decision Date2016-01-22
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PW Guidewires is the device name listed in this FDA 510(k) record. The listed applicant is Tatara Vascular, LLC. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152497. 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 PW Guidewires?

PW Guidewires is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Tatara Vascular, LLC. The 510(k) number is K152497.

When did PW Guidewires receive FDA 510(k) clearance?

PW Guidewires received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152497.

Who is the listed applicant for PW Guidewires?

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

What is the FDA product code for PW Guidewires?

The FDA product code for PW Guidewires is DQX.

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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