FDA 510(k)

FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE

K-Number: K063363 · 2007-05-07

Decision Date2007-05-07

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Flexicath , Ltd.. It received FDA 510(k) clearance on 2007-05-07 under 510(k) number K063363. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE?

FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE is a medical device that received FDA 510(k) clearance on 2007-05-07. The listed applicant is Flexicath , Ltd.. The 510(k) number is K063363.

When did FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE receive FDA 510(k) clearance?

FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE received FDA 510(k) clearance on 2007-05-07, under 510(k) number K063363.

Who is the listed applicant for FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE?

The FDA 510(k) record lists Flexicath , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE?

The FDA product code for FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE is LJS.

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 Flexicath , Ltd. as applicant

K111939M/29TM - PRESSURE INJECTABLE K092629SNM FIRMGRIP K080793FIRMGRIP

Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.