FDA 510(k)

HydroPICC (PICC-142)

Numéro K : K193015 · 2020-02-20

Date de décision2020-02-20

Code produitLJS

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

HydroPICC (PICC-142) is the device name listed in this FDA 510(k) record. The listed applicant is Access Vascular, Inc.. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K193015. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HydroPICC (PICC-142)?

HydroPICC (PICC-142) is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Access Vascular, Inc.. The 510(k) number is K193015.

When did HydroPICC (PICC-142) receive FDA 510(k) clearance?

HydroPICC (PICC-142) received FDA 510(k) clearance on 2020-02-20, under 510(k) number K193015.

Who is the listed applicant for HydroPICC (PICC-142)?

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

What is the FDA product code for HydroPICC (PICC-142)?

The FDA product code for HydroPICC (PICC-142) is LJS.

Essais cliniques associés

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Autres dossiers indiquant Access Vascular, Inc. en tant que demandeur

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); Hydr K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)K220772HydroMID 4F Single Lumen Midline Catheter K213550HydroPICC 5F Dual Lumen Catheter

Voir tous les 9 dispositifs →

Dispositifs connexes (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.

Source officielle

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