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FDA 510(k)

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM

K-Number: K913746 · 1991-12-17

ApplicantPeripheral Systems Group
Decision Date1991-12-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM 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 1991-12-17 under 510(k) number K913746. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM?

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Peripheral Systems Group. The 510(k) number is K913746.

When did SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1991-12-17, under 510(k) number K913746.

Who is the listed applicant for SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM?

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 SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM?

The FDA product code for SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM is ITX.

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.

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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 CATHETERK931327PSG DIRECTIONAL HYDROPHILIC GUIDE WIREK915554HI-TORQUE SPORT-T(TM) GUIDE WIREK914979EDM(R) INFUSION CATHETER

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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