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FDA 510(k)

MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE

K-Number: K132623 · 2013-12-19

ApplicantMedtronic
Decision Date2013-12-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2013-12-19 under 510(k) number K132623. 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 MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE?

MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Medtronic. The 510(k) number is K132623.

When did MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE receive FDA 510(k) clearance?

MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE received FDA 510(k) clearance on 2013-12-19, under 510(k) number K132623.

Who is the listed applicant for MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE?

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

What is the FDA product code for MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE?

The FDA product code for MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE is DQX.

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Related Devices (Code: DQX)

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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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