FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K Number: K071846
·
Decision Aug 30, 2007
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
13
Review Days
56
Basic Information
- Device Name
- MODIFICATION TO EZ HUBER SAFETY INFUSION SET
- K Number
- K071846
- 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
- July 5, 2007
- Decision Date
- August 30, 2007
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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 | ||
|---|---|---|---|
| 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 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Feb 26, 2010 | Unknown |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Nov 6, 2009 | Substantially Equivalent |
| K083873 | PICC (CT RATED AND NON-RATED) | Mar 19, 2009 | Substantially Equivalent |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | Mar 7, 2008 | Substantially Equivalent |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | Dec 12, 2007 | Substantially Equivalent |
| K072391 | PFM PICC | Nov 19, 2007 | Substantially Equivalent |