FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUAL SPIKE TRANSFER DEVICE
K Number: K120150
·
Decision May 24, 2012
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
200
Applicant Total
110
Review Days
127
Basic Information
- Device Name
- DUAL SPIKE TRANSFER DEVICE
- K Number
- K120150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. BRAUN MEDICAL, INC.
- Date Received
- January 18, 2012
- Decision Date
- May 24, 2012
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHI), ordered by most recent decision date.
Arisure® Closed Male Luer with Spike Adapter (YM060)
FDA 510(k)
FDA Class 2
·General Hospital
Rio Drug Reconstitution Transfer Device
FDA 510(k)
FDA Class 2
·General Hospital
SmartSiteTM Vented Vial Access Device
FDA 510(k)
FDA Class 2
·General Hospital
nextaro® va, 15mm, 5µm
FDA 510(k)
FDA Class 2
·General Hospital
Vent Vial Adapter
FDA 510(k)
FDA Class 2
·General Hospital
FlowArt Valve for Vial Access
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by B. BRAUN MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K140838 | IV ADMINISTRATION SET WITH HAND PUMP | Dec 5, 2014 | Substantially Equivalent |
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS | Aug 25, 2014 | Substantially Equivalent |
| K140311 | CARESITE LUER ACCESS DEVICE | May 7, 2014 | Substantially Equivalent |
| K130857 | PRONTOSAN WOUND GEL X | Oct 8, 2013 | Substantially Equivalent |
| K131842 | STERICAN CANNULA | Aug 20, 2013 | Substantially Equivalent |
| K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | Nov 20, 2012 | Substantially Equivalent |
| K113059 | CONTIPLEX FX | Jan 24, 2012 | Substantially Equivalent |
| K112515 | PENCAN SPINAL NEEDLE | Dec 22, 2011 | Substantially Equivalent |
| K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR | Nov 26, 2011 | Substantially Equivalent |
| K110744 | PRONTOSAN WOUND IRRIGATION SOLUTION | Apr 6, 2011 | Substantially Equivalent |