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FDA 510(k)

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT

K-Number: K946029 · 1995-02-24

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1995-02-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT 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 1995-02-24 under 510(k) number K946029. 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 ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT?

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K946029.

When did ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT receive FDA 510(k) clearance?

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT received FDA 510(k) clearance on 1995-02-24, under 510(k) number K946029.

Who is the listed applicant for ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT?

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 ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT?

The FDA product code for ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT is DQX.

Related Clinical Trials

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.

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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

View all 103 devices →

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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