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FDA 510(k)

SILICONE COATED GUIDEWIRE

K-Number: K041740 · 2004-10-15

ApplicantArrow International, Inc.
Decision Date2004-10-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SILICONE COATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc.. It received FDA 510(k) clearance on 2004-10-15 under 510(k) number K041740. 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 SILICONE COATED GUIDEWIRE?

SILICONE COATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2004-10-15. The listed applicant is Arrow International, Inc.. The 510(k) number is K041740.

When did SILICONE COATED GUIDEWIRE receive FDA 510(k) clearance?

SILICONE COATED GUIDEWIRE received FDA 510(k) clearance on 2004-10-15, under 510(k) number K041740.

Who is the listed applicant for SILICONE COATED GUIDEWIRE?

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

What is the FDA product code for SILICONE COATED GUIDEWIRE?

The FDA product code for SILICONE COATED 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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