FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PleurX Peritoneal Catheter System
K Number: K201155
·
Decision Oct 21, 2020
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
14
Applicant Total
34
Review Days
174
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Basic Information
- Device Name
- PleurX Peritoneal Catheter System
- K Number
- K201155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Care Fusion
- Date Received
- April 30, 2020
- Decision Date
- October 21, 2020
- 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
ASEPT Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aspira Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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| K170405 | BD Curve Ascites Shunt | Nov 2, 2017 | Unknown |
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