LJS · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Classification details

Medical specialty

General Hospital

Review panel

HO

Regulation number

880.5970

Implant

Y

Life-sustain / support

N

GMP exempt

N

Third-party review

N

Sponsor	Clearances	Last 12 mo	Most recent
Access Vascular, Inc.	5	0	2025-08-01
Piccolo Medical, Inc.	4	1	2025-11-17
L&Z Us, Inc.	3	0	2023-12-01
Navi Medical Technologies	2	1	2026-04-17
Bard Access Systems, Inc.	2	0	2022-08-24
Argon Medical Devices	1	0	2023-11-30
C.R. Bard, Inc.	1	0	2021-03-12
Spectrum Vascular	1	1	2025-12-16
Biowy Corporation	1	0	2020-04-30
Arrow International, LLC (A subsidiary of Teleflex, Inc.)	1	0	2022-08-22
Vygon Corporation	1	0	2025-02-26

Code	Type	Description	Confidence	Rationale
36568	CPT	—	High	CPT code for insertion of long-term intravascular catheter (PICC or similar)
36569	CPT	—	High	CPT code for replacement of long-term intravascular catheter

Date	K-number	Sponsor	Device
2026-04-17	K260929	Navi Medical Technologies	Neonav ECG Tip Location System
2025-12-16	K252373	Spectrum Vascular	BioFlo 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 Technology
2025-11-17	K252792	Piccolo Medical, Inc.	PM2 System with ECGuide Connector
2025-08-01	K243458	Access Vascular, Inc.	HydroPICC 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
2025-07-01	K251212	Access Vascular, Inc.	Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
2025-05-29	K243484	Piccolo Medical, Inc.	PM2+ System and SmartPICC Stylet
2025-02-26	K241587	Vygon Corporation	pilot TLS
2025-01-19	K241910	Navi Medical Technologies	Neonav ECG Tip Location System
2025-01-17	K243941	Access Vascular, Inc.	HydroPICC 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)
2024-09-08	K240486	Piccolo Medical, Inc.	PM2 System and ECGuide Connector
2023-12-01	K233149	L&Z Us, Inc.	CATHTONG III Tapered PICC Catheter
2023-11-30	K230669	Argon Medical Devices	L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters
2023-09-22	K232594	L&Z Us, Inc.	CATHTONG II PICC Catheter
2023-09-22	K232571	L&Z Us, Inc.	CATHTONG II PICC Catheter
2022-08-24	K222232	Bard Access Systems, Inc.	Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
2022-08-22	K220363	Arrow International, LLC (A subsidiary of Teleflex, Inc.)	VPS Rhythm DLX Device with TipTracker Technology
2022-05-04	K213550	Access Vascular, Inc.	HydroPICC 5F Dual Lumen Catheter
2021-07-30	K210264	Bard Access Systems, Inc.	BD PowerPiCC Catheter
2021-03-12	K201452	C.R. Bard, Inc.	Groshong NXT PICC Catheter
2021-01-22	K200037	Piccolo Medical, Inc.	Piccolo Medical SmartPICC System
2020-04-30	K192246	Biowy Corporation	Biowy PICC Catheter S Kit
2020-02-20	K193015	Access Vascular, Inc.	HydroPICC (PICC-142)

LJS · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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