PM2+ System and SmartPICC Stylet

Q: What is the product code of K243484?

The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.

FDA 510(k) K243484 · Piccolo Medical, Inc.

Substantially Equivalent

510(k) numberK243484

Submission

Device name: PM2+ System and SmartPICC Stylet
Applicant: Piccolo Medical, Inc.
San Francisco, CA, US
Received: November 8, 2024
Decision date: May 29, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5970
Specialty: General Hospital
Implant: Yes

Other 510(k)s with product code LJS

510(k)	Device	Applicant	Decision
K260929	Neonav ECG Tip Location SystemLJS · Special	Navi Medical Technologies	04/17/2026SE
K252373	BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional	Spectrum Vascular	12/16/2025SE
K252792	PM2 System with ECGuide ConnectorLJS · Special	Piccolo Medical, Inc.	11/17/2025SE
K243458	HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional	Access Vascular, Inc.	08/01/2025SE
K251212	Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special	Access Vascular, Inc.	07/01/2025SE
K241587	pilot TLSLJS · Traditional	Vygon Corporation	02/26/2025SE
K241910	Neonav ECG Tip Location SystemLJS · Traditional	Navi Medical Technologies	01/19/2025SE
K243941	HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special	Access Vascular, Inc.	01/17/2025SE
K240486	PM2 System and ECGuide ConnectorLJS · Traditional	Piccolo Medical, Inc.	09/08/2024SE
K233149	CATHTONG III Tapered PICC CatheterLJS · Special	L&Z Us, Inc.	12/01/2023SE

More from L&Z Us, Inc.

510(k)	Device	Decision
K252792	PM2 System with ECGuide ConnectorLJS · Special	11/17/2025SE
K240486	PM2 System and ECGuide ConnectorLJS · Traditional	09/08/2024SE
K200037	Piccolo Medical SmartPICC SystemLJS · Traditional	01/22/2021SE

Questions and answers

When was PM2+ System and SmartPICC Stylet cleared by the FDA?

PM2+ System and SmartPICC Stylet (K243484) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 202 days after the submission was received.

What is the product code of K243484?

The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.