FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JetCan® Pro Safety Huber Needle
K Number: K242763
·
Decision May 2, 2025
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
20
Review Days
232
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Basic Information
- Device Name
- JetCan® Pro Safety Huber Needle
- K Number
- K242763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pfm Medical, Inc.
- Date Received
- September 12, 2024
- Decision Date
- May 2, 2025
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Pfm Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Mar 13, 2012 | Unknown |
| K110914 | TRIPLE LUMEN PFM PICC | Sep 21, 2011 | Substantially Equivalent |