FDA.report

510(k) K252792

Device
PM2™ System with ECGuide™ Connector
Applicant
Piccolo Medical, Inc.
510(k) number
K252792
Product code
LJS
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-17
Date received
2025-09-02
Regulation
880.5970
Classification name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Augustus Shanahan
Address
218 Mississippi St. San Francisco CA US 94107 94107

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LJS

510(k)DeviceApplicantDecision date
K260929Neonav ECG Tip Location SystemNavi Medical Technologies2026-04-17
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 Vascular2025-12-16
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.2025-08-01
K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.2025-07-01
K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.2025-05-29
K241587pilot TLSVygon Corporation2025-02-26
K241910Neonav ECG Tip Location SystemNavi Medical Technologies2025-01-19
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)Access Vascular, Inc.2025-01-17
K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc.2024-09-08
K233149CATHTONG III Tapered PICC CatheterL&Z Us, Inc.2023-12-01
K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices2023-11-30
K232594CATHTONG™ II PICC CatheterL&Z Us, Inc.2023-09-22
K232571CATHTONG™ II PICC CatheterL&Z Us, Inc.2023-09-22
K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc.2022-08-24
K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.)2022-08-22