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FDA 510(k)

SELECTIVA GUIDEWIRE

K-Number: K013024 · 2001-12-04

ApplicantNeometrics, Inc.
Decision Date2001-12-04
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELECTIVA GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 2001-12-04 under 510(k) number K013024. 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 SELECTIVA GUIDEWIRE?

SELECTIVA GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2001-12-04. The listed applicant is Neometrics, Inc.. The 510(k) number is K013024.

When did SELECTIVA GUIDEWIRE receive FDA 510(k) clearance?

SELECTIVA GUIDEWIRE received FDA 510(k) clearance on 2001-12-04, under 510(k) number K013024.

Who is the listed applicant for SELECTIVA GUIDEWIRE?

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

What is the FDA product code for SELECTIVA GUIDEWIRE?

The FDA product code for SELECTIVA GUIDEWIRE is DQX.

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Other records listing Neometrics, Inc. as applicant

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.

K123439NEO ERCP GUIDEWIREK101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIRE

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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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