FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Extension Set with BD Q-Syte Luer Access Split Septum
K Number: K142527
·
Decision Sep 19, 2014
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
17
Review Days
11
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Basic Information
- Device Name
- Extension Set with BD Q-Syte Luer Access Split Septum
- K Number
- K142527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acacia, Inc.
- Date Received
- September 8, 2014
- Decision Date
- September 19, 2014
- 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 Acacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122449 | ENTERAL NUTRITION WARMER | Jun 13, 2013 | Substantially Equivalent |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Jan 13, 2012 | Substantially Equivalent |
| K103165 | BLOOD SAMPLING SET | Nov 10, 2010 | Substantially Equivalent |
| K092986 | ACACIA PISTON SYRINGE | Oct 27, 2009 | Substantially Equivalent |
| K972538 | FLOW-EZE BLUNT CANNULA (1999BC) | Jul 15, 1998 | Substantially Equivalent |
| K931095 | SPRING LOADED SYRINGE | Sep 16, 1993 | Substantially Equivalent |
| K912771 | ACACIAS PHARM/PUMP | Feb 14, 1992 | Substantially Equivalent |
| K901063 | LUER LOCK TRANSFER PIN | Jul 6, 1990 | Substantially Equivalent |
| K896990 | PHARMULATOR | Mar 23, 1990 | Substantially Equivalent |
| K894206 | INTOPO | Oct 27, 1989 | Substantially Equivalent |