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FDA 510(k)

BACK-UP MEIER GUIDEWIRE

K-Number: K011906 · 2001-08-13

ApplicantBoston Scientific Corp
Decision Date2001-08-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BACK-UP MEIER 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 2001-08-13 under 510(k) number K011906. 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 BACK-UP MEIER GUIDEWIRE?

BACK-UP MEIER GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2001-08-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K011906.

When did BACK-UP MEIER GUIDEWIRE receive FDA 510(k) clearance?

BACK-UP MEIER GUIDEWIRE received FDA 510(k) clearance on 2001-08-13, under 510(k) number K011906.

Who is the listed applicant for BACK-UP MEIER 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 BACK-UP MEIER GUIDEWIRE?

The FDA product code for BACK-UP MEIER 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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