FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
K Number: K060866
·
Decision Apr 28, 2006
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
7
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
- K Number
- K060866
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carmel Pharma Ab.
- Date Received
- March 30, 2006
- Decision Date
- April 28, 2006
- 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.
ADRx Admixture Device
FDA 510(k)
FDA Class 2
·General Hospital
Vial Adapter
FDA 510(k)
FDA Class 2
·General Hospital
Medline Bag Decanter
FDA 510(k)
FDA Class 2
·General Hospital
FlowArt® Vial Access Device Vented
FDA 510(k)
FDA Class 2
·General Hospital
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
FDA 510(k)
FDA Class 2
·General Hospital
HyHub and HyHub Duo Vial Access Devices
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Carmel Pharma Ab.
| K Number | Device Name | ||
|---|---|---|---|
| K110023 | INFUSION ADAPTER C100 | Apr 12, 2011 | Substantially Equivalent |
| K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | Dec 7, 2009 | Substantially Equivalent |
| K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | Mar 23, 2009 | Substantially Equivalent |
| K023747 | PHASEAL | Nov 15, 2002 | Substantially Equivalent |
| K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER | May 12, 2000 | Substantially Equivalent |
| K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO | Mar 3, 1998 | Substantially Equivalent |