PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-
FDA 510(k) clearance K241946 · decided 2024-12-06
Clearance details
- K-number
- K241946
- Device name
- PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-03
- Decision date
- 2024-12-06
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- PNG
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ASEPT® Glide Peritoneal Drainage System (K241278) | Pfm Medical, Inc. | 2025-01-14 |
| Passio Pump Drainage System (K230319) | Bearpac Medical | 2023-11-24 |
| ASEPT Peritoneal Drainage System (K221779) | Pfm Medical, Inc. | 2023-05-02 |
| Aspira Peritoneal Drainage System (K212675) | Merit Medical Systems, Inc. | 2021-12-14 |
| PleurX Peritoneal Catheter System (K201155) | Care Fusion | 2020-10-21 |
| Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K162457) | Rocket Medical Plc | 2016-11-14 |
| PleurX Peritoneal Catheter System (K160437) | Care Fusion | 2016-11-03 |
| Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (K152105) | Rocket Medical Plc | 2016-03-29 |
| PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER (K122422) | Care Fusion | 2012-10-24 |
| PLEURX PERITONEAL CATHETER SYSTEM (K113854) | Care Fusion | 2012-03-19 |
| ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396) | C.R. Bard, Inc. | 2011-05-06 |
| ASEPT PERITONEAL DRAINAGE SYSTEM (K093796) | Pfm Medical, Inc. | 2010-02-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S013) | Bard Peripheral Vascular, Inc. | 2025-08-13 |
| Venovo Venous Stent System (P180037/S014) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S013) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStent Vascular Stent System (P070014/S065) | Bard Peripheral Vascular, Inc. | 2023-07-27 |
| Fluency Endovascular Stent Graft (P130029/S012) | Bard Peripheral Vascular, Inc. | 2023-02-17 |
| LifeStent 5F Vascular Stent Systems (P070014/S064) | Bard Peripheral Vascular, Inc. | 2023-02-02 |