FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ASEPT Peritoneal Drainage System
K Number: K221779
·
Decision May 2, 2023
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
14
Applicant Total
20
Review Days
315
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Basic Information
- Device Name
- ASEPT Peritoneal Drainage System
- K Number
- K221779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Pfm Medical, Inc.
- Date Received
- June 21, 2022
- Decision Date
- May 2, 2023
- Product Code
- PNG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNG), ordered by most recent decision date.
ASEPT® Glide Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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)
FDA Class 2
·Gastroenterology, Urology
Passio Pump Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aspira Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PleurX Peritoneal Catheter System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Pfm Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242763 | JetCan® Pro Safety Huber Needle | May 2, 2025 | Substantially Equivalent |
| K241278 | ASEPT® Glide Peritoneal Drainage System | Jan 14, 2025 | Substantially Equivalent |
| K213666 | NuCath Wedge Pressure Catheter | Oct 6, 2022 | Substantially Equivalent |
| K201137 | Asept Surgical Face Mask | Aug 19, 2020 | Substantially Equivalent |
| K192802 | primeMidline Catheters | Oct 28, 2019 | Substantially Equivalent |
| K173114 | primeMidline Catheters | Mar 7, 2018 | Substantially Equivalent |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | Mar 25, 2014 | Substantially Equivalent |
| K122402 | LPP (LOW PROFILE PORT) | Jul 16, 2013 | Substantially Equivalent |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Mar 13, 2012 | Unknown |
| K110914 | TRIPLE LUMEN PFM PICC | Sep 21, 2011 | Substantially Equivalent |