510(k) K241946
- Device
- 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 Mi
- Applicant
- Bard Peripheral Vascular, Inc.
- 510(k) number
- K241946
- Product code
- PNG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-06
- Date received
- 2024-07-03
- Regulation
- 876.5630
- Classification name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gabrielle Wipper
- Address
- 1625 W. 3rd St. Tempe AZ US 85281 85281
FDA Registration Numbers#
- 3006950086
- 1061124
- 3010155661
- 3013188547
- 3033589330
- 3010308146
- 3030626857
- 1721504
- 1724474
- 1625685
- 1018233
- 9680904
- 3013557562
- 3013666218
- 3015715211
- 3011642792
- 3012536737
- 3015225571
- 3011534620
- 2030624
- 3014579161
- 9610632
- 1423507
- 9617592
- 3013298431
- 2020394
- 3015309643
- 3006082230
Source Documents#
Other 510(k) Records For Product Code PNG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025-01-14 |
| K230319 | Passio Pump Drainage System | Bearpac Medical | 2023-11-24 |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023-05-02 |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | 2021-12-14 |
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020-10-21 |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2016-11-14 |
| K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016-11-03 |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | 2016-03-29 |
| K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER | Care Fusion | 2012-10-24 |
| K113854 | PLEURX PERITONEAL CATHETER SYSTEM | Care Fusion | 2012-03-19 |
| K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-06 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2010-02-26 |
| K081288 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2008-07-18 |
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | Denver Biomedical, Inc. | 2005-11-15 |