FDA 510(k)

GUIDE, WIRE, ANGIOGRAPHIC

K-Number: K850827 · 1985-06-26

Decision Date1985-06-26

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GUIDE, WIRE, ANGIOGRAPHIC 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 K850827. 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 GUIDE, WIRE, ANGIOGRAPHIC?

GUIDE, WIRE, ANGIOGRAPHIC 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 K850827.

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

GUIDE, WIRE, ANGIOGRAPHIC received FDA 510(k) clearance on 1985-06-26, under 510(k) number K850827.

Who is the listed applicant for GUIDE, WIRE, ANGIOGRAPHIC?

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 GUIDE, WIRE, ANGIOGRAPHIC?

The FDA product code for GUIDE, WIRE, ANGIOGRAPHIC is DQX.

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

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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.