FDA 510(k)

RUNTHROUGH NS EXTENSION WIRE

K-Number: K080563 · 2008-03-20

Decision Date2008-03-20

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RUNTHROUGH NS EXTENSION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K080563. 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 RUNTHROUGH NS EXTENSION WIRE?

RUNTHROUGH NS EXTENSION WIRE is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Terumo Medical Corp.. The 510(k) number is K080563.

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

RUNTHROUGH NS EXTENSION WIRE received FDA 510(k) clearance on 2008-03-20, under 510(k) number K080563.

Who is the listed applicant for RUNTHROUGH NS EXTENSION WIRE?

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

What is the FDA product code for RUNTHROUGH NS EXTENSION WIRE?

The FDA product code for RUNTHROUGH NS EXTENSION WIRE 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 Terumo Medical Corp. as applicant

K111606PINNACLE PRECISION ACCESS SYSTEM K111556GLIDECROSS SUPPORT CATHETER K110540TERUMO SUPPORT CATHETER K102008GLIDESHEATH K091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH K082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

View all 143 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.