FDA 510(k)

LUGE GUIDE WIRE

K-Number: K973945 · 1998-01-12

Decision Date1998-01-12

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LUGE GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K973945. 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 LUGE GUIDE WIRE?

LUGE GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K973945.

When did LUGE GUIDE WIRE receive FDA 510(k) clearance?

LUGE GUIDE WIRE received FDA 510(k) clearance on 1998-01-12, under 510(k) number K973945.

Who is the listed applicant for LUGE GUIDE WIRE?

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

What is the FDA product code for LUGE GUIDE WIRE?

The FDA product code for LUGE GUIDE WIRE is DQX.

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Other records listing Scimed Life Systems, Inc. as applicant

K974241SCIMED INFORMER PRESSURE WIRE SYSTEM K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER K980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES K974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER K970823SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER

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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.