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FDA 510(k)

NEOWIRE PTA/PTCA GUIDEWIRE

K-Number: K101729 · 2010-09-23

ApplicantNeometrics, Inc.
Decision Date2010-09-23
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEOWIRE PTA/PTCA 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 2010-09-23 under 510(k) number K101729. 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 NEOWIRE PTA/PTCA GUIDEWIRE?

NEOWIRE PTA/PTCA GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-09-23. The listed applicant is Neometrics, Inc.. The 510(k) number is K101729.

When did NEOWIRE PTA/PTCA GUIDEWIRE receive FDA 510(k) clearance?

NEOWIRE PTA/PTCA GUIDEWIRE received FDA 510(k) clearance on 2010-09-23, under 510(k) number K101729.

Who is the listed applicant for NEOWIRE PTA/PTCA 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 NEOWIRE PTA/PTCA GUIDEWIRE?

The FDA product code for NEOWIRE PTA/PTCA GUIDEWIRE is DQX.

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Other records listing Neometrics, Inc. as applicant

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K123439NEO ERCP GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIREK031652VASCUPUNCTURE PICC 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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