FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
primeMidline Catheters
K Number: K173114
·
Decision Mar 7, 2018
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
12
Applicant Total
20
Review Days
159
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Basic Information
- Device Name
- primeMidline Catheters
- K Number
- K173114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pfm Medical, Inc.
- Date Received
- September 29, 2017
- Decision Date
- March 7, 2018
- Product Code
- PND
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PND | Midline Catheter | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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FDA 510(k)
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Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| 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 |
| 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 |