FDA 510(k)

DOCKING-EXTENSION WIRE

K-Number: K982592 · 1998-10-21

Decision Date1998-10-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DOCKING-EXTENSION 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 1998-10-21 under 510(k) number K982592. 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 DOCKING-EXTENSION WIRE?

DOCKING-EXTENSION WIRE is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Schneider (Europe) GmbH. The 510(k) number is K982592.

When did DOCKING-EXTENSION WIRE receive FDA 510(k) clearance?

DOCKING-EXTENSION WIRE received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982592.

Who is the listed applicant for DOCKING-EXTENSION 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 DOCKING-EXTENSION WIRE?

The FDA product code for DOCKING-EXTENSION WIRE is DQX.

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Other records listing Schneider (Europe) GmbH as applicant

K984068FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS K970528CLYDE CORONARY GUIDEWIRE K970494HANNIBAL GUIDEWIRE K951109C-THRU CORONARY GUIDE WIRE

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.