FDA 510(k)

0.014 PERIPHERAL GUIDE WIRE

K-Number: K882804 · 1988-10-28

Decision Date1988-10-28

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

0.014 PERIPHERAL GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1988-10-28 under 510(k) number K882804. 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 0.014 PERIPHERAL GUIDE WIRE?

0.014 PERIPHERAL GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1988-10-28. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K882804.

When did 0.014 PERIPHERAL GUIDE WIRE receive FDA 510(k) clearance?

0.014 PERIPHERAL GUIDE WIRE received FDA 510(k) clearance on 1988-10-28, under 510(k) number K882804.

Who is the listed applicant for 0.014 PERIPHERAL GUIDE WIRE?

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

What is the FDA product code for 0.014 PERIPHERAL GUIDE WIRE?

The FDA product code for 0.014 PERIPHERAL GUIDE WIRE is DQX.

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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.