FDA 510(k)

TRU-TRAC TORQUE GUIDEWIRE

K-Number: K880288 · 1988-09-12

Decision Date1988-09-12

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRU-TRAC TORQUE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is N-S Medical Products. It received FDA 510(k) clearance on 1988-09-12 under 510(k) number K880288. 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 TRU-TRAC TORQUE GUIDEWIRE?

TRU-TRAC TORQUE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1988-09-12. The listed applicant is N-S Medical Products. The 510(k) number is K880288.

When did TRU-TRAC TORQUE GUIDEWIRE receive FDA 510(k) clearance?

TRU-TRAC TORQUE GUIDEWIRE received FDA 510(k) clearance on 1988-09-12, under 510(k) number K880288.

Who is the listed applicant for TRU-TRAC TORQUE GUIDEWIRE?

The FDA 510(k) record lists N-S Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRU-TRAC TORQUE GUIDEWIRE?

The FDA product code for TRU-TRAC TORQUE GUIDEWIRE 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 N-S Medical Products as applicant

K880287TRU-TRAC COILED GUIDEWIRE K881956NATIONAL-STANDARD NEEDLE HOLDER K881957HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT K870523HAWKINS BREAST LOCALIZATION NEEDLE

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.