FDA 510(k)

NITREX NITINOL GUIDEWIRE

K-Number: K024021 · 2003-01-24

Decision Date2003-01-24

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NITREX NITINOL GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Corporation. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K024021. 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 NITREX NITINOL GUIDEWIRE?

NITREX NITINOL GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Ev3 Corporation. The 510(k) number is K024021.

When did NITREX NITINOL GUIDEWIRE receive FDA 510(k) clearance?

NITREX NITINOL GUIDEWIRE received FDA 510(k) clearance on 2003-01-24, under 510(k) number K024021.

Who is the listed applicant for NITREX NITINOL GUIDEWIRE?

The FDA 510(k) record lists Ev3 Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITREX NITINOL GUIDEWIRE?

The FDA product code for NITREX NITINOL GUIDEWIRE is DQX.

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Other records listing Ev3 Corporation as applicant

K051379PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT K050725PROTEGE GPS SELF-EXPANDING NITINOL STENT K021096X-SIZER CATHETER SYSTEM K031864NITREX NITINOL GUIDEWIRE

Related Devices (Code: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.