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FDA 510(k)

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF

K-Number: K914828 · 1992-01-08

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1992-01-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1992-01-08 under 510(k) number K914828. 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 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF?

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF is a medical device that received FDA 510(k) clearance on 1992-01-08. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K914828.

When did 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF receive FDA 510(k) clearance?

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF received FDA 510(k) clearance on 1992-01-08, under 510(k) number K914828.

Who is the listed applicant for 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF?

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

What is the FDA product code for 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF?

The FDA product code for 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF is DQX.

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Other records listing Advanced Cardiovascular Systems, 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.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

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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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