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FDA 510(k)

ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE

K-Number: K090554 · 2009-07-02

ApplicantBoston Scientific Corp
Decision Date2009-07-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K090554. 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 ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE?

ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Boston Scientific Corp. The 510(k) number is K090554.

When did ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE receive FDA 510(k) clearance?

ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE received FDA 510(k) clearance on 2009-07-02, under 510(k) number K090554.

Who is the listed applicant for ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE?

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

What is the FDA product code for ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE?

The FDA product code for ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE is DQX.

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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.

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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