FDA 510(k)

VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO

K-Number: K051062 · 2005-07-15

Decision Date2005-07-15

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2005-07-15 under 510(k) number K051062. 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 VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO?

VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO is a medical device that received FDA 510(k) clearance on 2005-07-15. The listed applicant is Flowcardia, Inc.. The 510(k) number is K051062.

When did VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO receive FDA 510(k) clearance?

VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO received FDA 510(k) clearance on 2005-07-15, under 510(k) number K051062.

Who is the listed applicant for VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO?

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

What is the FDA product code for VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO?

The FDA product code for VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO is DQX.

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Other records listing Flowcardia, Inc. as applicant

K092175THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 K091254THE CROSSER 14 OTW CATHETER, MODEL CRU014 K091119MODIFICATION TO THE CROSSER SYSTEM K080849MICROSHEATH LP AND LP-AT K080765CROSSER LP SYSTEM

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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.