FDA 510(k)

VASCUPUNCTURE ACCESS WIRE

K-Number: K012861 · 2002-02-05

Decision Date2002-02-05

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VASCUPUNCTURE ACCESS WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 2002-02-05 under 510(k) number K012861. 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 VASCUPUNCTURE ACCESS WIRE?

VASCUPUNCTURE ACCESS WIRE is a medical device that received FDA 510(k) clearance on 2002-02-05. The listed applicant is Neometrics, Inc.. The 510(k) number is K012861.

When did VASCUPUNCTURE ACCESS WIRE receive FDA 510(k) clearance?

VASCUPUNCTURE ACCESS WIRE received FDA 510(k) clearance on 2002-02-05, under 510(k) number K012861.

Who is the listed applicant for VASCUPUNCTURE ACCESS WIRE?

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 VASCUPUNCTURE ACCESS WIRE?

The FDA product code for VASCUPUNCTURE ACCESS WIRE is DQX.

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Other records listing Neometrics, Inc. as applicant

K123439NEO ERCP GUIDEWIRE K101729NEOWIRE PTA/PTCA GUIDEWIRE K070150VASCUPUNCTURE PICC GUIDEWIRE K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE K040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING K033321SELECTIVA SB GUIDEWIRE

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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

View on FDA Database →

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