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FDA 510(k)

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

K-Number: K010511 · 2001-03-01

ApplicantCordis Neurovascular, Inc.
Decision Date2001-03-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K010511. 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 MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES?

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K010511.

When did MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES receive FDA 510(k) clearance?

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES received FDA 510(k) clearance on 2001-03-01, under 510(k) number K010511.

Who is the listed applicant for MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES?

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

What is the FDA product code for MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES?

The FDA product code for MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES is DQX.

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Other records listing Cordis Neurovascular, Inc. as applicant

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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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