FDA 510(k)

C-THRU CORONARY GUIDE WIRE

K-Number: K951109 · 1995-06-08

Decision Date1995-06-08

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

C-THRU CORONARY GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Schneider (Europe) GmbH. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K951109. 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 C-THRU CORONARY GUIDE WIRE?

C-THRU CORONARY GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Schneider (Europe) GmbH. The 510(k) number is K951109.

When did C-THRU CORONARY GUIDE WIRE receive FDA 510(k) clearance?

C-THRU CORONARY GUIDE WIRE received FDA 510(k) clearance on 1995-06-08, under 510(k) number K951109.

Who is the listed applicant for C-THRU CORONARY GUIDE WIRE?

The FDA 510(k) record lists Schneider (Europe) GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-THRU CORONARY GUIDE WIRE?

The FDA product code for C-THRU CORONARY GUIDE WIRE is DQX.

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Other records listing Schneider (Europe) GmbH as applicant

K984068FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS K982592DOCKING-EXTENSION WIRE K970528CLYDE CORONARY GUIDEWIRE K970494HANNIBAL GUIDEWIRE

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

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