FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VETA PERITONEAL DIALYSIS CATHETER
K Number: K113354
·
Decision Mar 13, 2012
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
47
Applicant Total
20
Review Days
120
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Basic Information
- Device Name
- VETA PERITONEAL DIALYSIS CATHETER
- K Number
- K113354
- 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
- November 14, 2011
- Decision Date
- March 13, 2012
- Product Code
- FJS
- 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
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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 |
| K221779 | ASEPT Peritoneal Drainage System | May 2, 2023 | Unknown |
| 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 |
| K110914 | TRIPLE LUMEN PFM PICC | Sep 21, 2011 | Substantially Equivalent |