FDA 510(k)

GUIDE WIRE EXTENSION

K-Number: K915114 · 1992-02-11

Decision Date1992-02-11

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GUIDE WIRE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K915114. 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 EXTENSION?

GUIDE WIRE EXTENSION is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Target Therapeutics. The 510(k) number is K915114.

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

GUIDE WIRE EXTENSION received FDA 510(k) clearance on 1992-02-11, under 510(k) number K915114.

Who is the listed applicant for GUIDE WIRE EXTENSION?

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 GUIDE WIRE EXTENSION?

The FDA product code for GUIDE WIRE EXTENSION is DQX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Target Therapeutics as applicant

K965071DETACHABLE SLICONE BALLOON (DSB)K964488DETACHABLE SILICONE BALLOON (DSB)K964210RETRIEVER II K971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE K965189SPINNAKER K964112BERENSTEIN COIL

View all 70 devices →

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.