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FDA 510(k)

DASHER-14

K-Number: K950069 · 1995-04-12

ApplicantTarget Therapeutics
Decision Date1995-04-12
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DASHER-14 is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1995-04-12 under 510(k) number K950069. 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 DASHER-14?

DASHER-14 is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Target Therapeutics. The 510(k) number is K950069.

When did DASHER-14 receive FDA 510(k) clearance?

DASHER-14 received FDA 510(k) clearance on 1995-04-12, under 510(k) number K950069.

Who is the listed applicant for DASHER-14?

The FDA 510(k) record lists Target Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DASHER-14?

The FDA product code for DASHER-14 is DQX.

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Related Devices (Code: DQX)

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K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit 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.

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