FDA 510(k)

WIRE, GUIDE - MODIFICATION

K-Number: K850828 · 1985-06-26

Decision Date1985-06-26

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WIRE, GUIDE - MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1985-06-26 under 510(k) number K850828. 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 WIRE, GUIDE - MODIFICATION?

WIRE, GUIDE - MODIFICATION is a medical device that received FDA 510(k) clearance on 1985-06-26. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K850828.

When did WIRE, GUIDE - MODIFICATION receive FDA 510(k) clearance?

WIRE, GUIDE - MODIFICATION received FDA 510(k) clearance on 1985-06-26, under 510(k) number K850828.

Who is the listed applicant for WIRE, GUIDE - MODIFICATION?

The FDA 510(k) record lists Lake Region Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIRE, GUIDE - MODIFICATION?

The FDA product code for WIRE, GUIDE - MODIFICATION is DQX.

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Other records listing Lake Region Mfg., Inc. as applicant

K092965TRAILRUNNER GUIDEWIRES K082922FREEWAY AND RAILRUNNER GUIDEWIRES K081708TAXI ENDOSCOPIC GUIDEWIRE K080144MANDREL GUIDEWIRES OR M-WIRES K073655PEGASUS STEERABLE (PTCA) GUIDEWIRE K060454TITAN GUIDEWIRE

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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.