FDA 510(k)

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS

K-Number: K950752 · 1995-05-15

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1995-05-15

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS 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 1995-05-15 under 510(k) number K950752. 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 TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS?

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K950752.

When did ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS receive FDA 510(k) clearance?

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS received FDA 510(k) clearance on 1995-05-15, under 510(k) number K950752.

Who is the listed applicant for ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS?

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 TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS?

The FDA product code for ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS is DQX.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING K000550OTW MEGALINK SDS BILIARY STENT SYSTEM K994229VERIPATH PERIPHERAL GUIDING CATHETER K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

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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.