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FDA 510(k)

PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE

K-Number: K931327 · 1993-07-14

ApplicantPeripheral Systems Group
Decision Date1993-07-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Peripheral Systems Group. It received FDA 510(k) clearance on 1993-07-14 under 510(k) number K931327. 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 PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE?

PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1993-07-14. The listed applicant is Peripheral Systems Group. The 510(k) number is K931327.

When did PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE receive FDA 510(k) clearance?

PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE received FDA 510(k) clearance on 1993-07-14, under 510(k) number K931327.

Who is the listed applicant for PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE?

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

What is the FDA product code for PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE?

The FDA product code for PSG DIRECTIONAL HYDROPHILIC GUIDE 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Peripheral Systems Group as applicant

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.

K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONK934433VANTAGE DIALTAION CATHETERK932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETERK915554HI-TORQUE SPORT-T(TM) GUIDE WIREK914979EDM(R) INFUSION CATHETERK913941PSG(TM) 20 GUAGE DOPPLER NEEDLE

View all 17 devices →

Related Devices (Code: DQX)

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.

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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