510(k) K241587

Device: pilot TLS
Applicant: Vygon Corporation
510(k) number: K241587
Product code: LJS
Decision: Substantially Equivalent (SESE)
Decision date: 2025-02-26
Date received: 2024-06-03
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: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Chris Steinke
Address: 2750 Morris Rd. Suite A200 Lansdale Montgomery PA US 19446 19446

FDA Registration Numbers

3004134316
3007697249
3010827261
9617592
1061124
2183744
3012536737
3007137787
3010882065
3006260740
1644312
3021570645
1833566
3005636544
3013233645
1718873
3013557562
2246552
2133772
1423537
1721676
1820334
3006425876
3013750125
3012307300
3013788631
3006950086
3033589330
3013162291
3003915875
1018233
3013666218
1625425
3035111606
1000484830
3030714660
3015060216
3004753388
1722746
3013501772
3015537049
3011534620
1724474
3015859709
1319639
3016727301
3038181770
3013041594
2245270
9681477
3006942602
3007207906
2030624
3007544874
3016472589
1921846
1647149
1223004
3009888344
3005704822
1220477
3030148766
1000314502
3011237770
1643817
3003898360
1721686
1225492
9681202
1048735
3004111573
1424778
2518902
9612433
3010041511
1319211
2527072
3024673
9680794
3009211636
3010532612
3015225571
3006082230
3010882708
3011137372
3015309643
2011171
1721504
9617604
1219930
3018094310

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LJS

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K260929	Neonav ECG Tip Location System	Navi Medical Technologies	2026-04-17
K252373	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	Spectrum Vascular	2025-12-16
K252792	PM2 System with ECGuide Connector	Piccolo Medical, Inc.	2025-11-17
K243458	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	Access Vascular, Inc.	2025-08-01
K251212	Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)	Access Vascular, Inc.	2025-07-01
K243484	PM2+ System and SmartPICC Stylet	Piccolo Medical, Inc.	2025-05-29
K241910	Neonav ECG Tip Location System	Navi Medical Technologies	2025-01-19
K243941	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)	Access Vascular, Inc.	2025-01-17
K240486	PM2 System and ECGuide Connector	Piccolo Medical, Inc.	2024-09-08
K233149	CATHTONG III Tapered PICC Catheter	L&Z Us, Inc.	2023-12-01
K230669	L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters	Argon Medical Devices	2023-11-30
K232594	CATHTONG II PICC Catheter	L&Z Us, Inc.	2023-09-22
K232571	CATHTONG II PICC Catheter	L&Z Us, Inc.	2023-09-22
K222232	Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly	Bard Access Systems, Inc.	2022-08-24
K220363	VPS Rhythm DLX Device with TipTracker Technology	Arrow International, LLC (A subsidiary of Teleflex, Inc.)	2022-08-22