510(k) K093796
- Device
- ASEPT PERITONEAL DRAINAGE SYSTEM
- Applicant
- PFM MEDICAL, INC
- 510(k) number
- K093796
- Product code
- PNG
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2010-02-26
- Date received
- 2009-12-11
- 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
- SALVADORE PALOMARES
- Address
- 2605 Temple Heights Dr. Suite A Oceanside CA US 92056 92056
FDA Registration Numbers#
- 3011642792
- 3013557562
- 3013188547
- 3030626857
- 3010308146
- 1018233
- 3011534620
- 9680904
- 3013298431
- 1061124
- 3013666218
- 3014579161
- 3015309643
- 2020394
- 1625685
- 9617592
- 3012536737
- 9610632
- 3006082230
- 2030624
- 1724474
- 3033589330
- 3015225571
- 3015715211
- 3010155661
- 1721504
- 3006950086
- 1423507
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 |
| K241946 | 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- | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| 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 |
| 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 |
Legacy Summary#
summary