510(k) K152409
- Device
- Xcela PICC With PASV, Xcela Hybrid PICC With PASV, Xcela Power Injectable PICC
- Applicant
- NAVILYST MEDICAL, INC.
- 510(k) number
- K152409
- Product code
- LJS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-24
- Date received
- 2015-08-26
- 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
- No
Applicant Contact#
- Contact
- ROBIN FULLER
- Address
- 26 Forest St. Marlborough MA US 01752 01752
FDA Registration Numbers#
- 1722746
- 3013233645
- 1000314502
- 1423537
- 3013501772
- 3006425876
- 3003898360
- 1000484830
- 3007544874
- 3010532612
- 2133772
- 3010882065
- 3005636544
- 3015060216
- 1424778
- 1625425
- 3010827261
- 3011237770
- 3005704822
- 9617604
- 3006260740
- 3013162291
- 3018094310
- 2011171
- 1048735
- 1319639
- 1018233
- 3003915875
- 3013041594
- 1721686
- 1219930
- 2245270
- 1220477
- 1921846
- 3006942602
- 3004111573
- 9617592
- 1644312
- 1643817
- 3016472589
- 1820334
- 3024673
- 3015859709
- 1061124
- 3004753388
- 2518902
- 3007137787
- 2527072
- 3009888344
- 1718873
- 2246552
- 3030714660
- 1223004
- 3033589330
- 3009211636
- 1225492
- 3013750125
- 3011534620
- 3035111606
- 9681202
- 1647149
- 3015225571
- 3006082230
- 9681477
- 3010041511
- 3038181770
- 3004134316
- 9612433
- 3013666218
- 2183744
- 3016727301
- 3021570645
- 3015309643
- 3006950086
- 3007697249
- 1721676
- 1721504
- 9680794
- 3015537049
- 3030148766
Source Documents#
Other 510(k) Records For Product Code LJS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K241587 | pilot TLS | Vygon Corporation | 2025-02-26 |
| 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 |
Legacy Summary#
summary
FDA Review#
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