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FDA 510(k)

Piccolo Medical SmartPICC System

K-Number: K200037 · 2021-01-22

ApplicantPiccolo Medical, Inc.
Decision Date2021-01-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Piccolo Medical SmartPICC System is the device name listed in this FDA 510(k) record. The listed applicant is Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K200037. 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 Piccolo Medical SmartPICC System?

Piccolo Medical SmartPICC System is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Piccolo Medical, Inc.. The 510(k) number is K200037.

When did Piccolo Medical SmartPICC System receive FDA 510(k) clearance?

Piccolo Medical SmartPICC System received FDA 510(k) clearance on 2021-01-22, under 510(k) number K200037.

Who is the listed applicant for Piccolo Medical SmartPICC System?

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

What is the FDA product code for Piccolo Medical SmartPICC System?

The FDA product code for Piccolo Medical SmartPICC System is LJS.

Other records listing Piccolo Medical, Inc. 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.

K252792PM2™ System with ECGuide™ ConnectorK243484PM2+ System and SmartPICC StyletK240486PM2 System and ECGuide Connector

Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo 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 VascularK252792PM2™ 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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