FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISECURE SYRINGE CARTRIDGE HOLDER
K Number: K063180
·
Decision Dec 11, 2006
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
2
Applicant Total
45
Review Days
53
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Basic Information
- Device Name
- ISECURE SYRINGE CARTRIDGE HOLDER
- K Number
- K063180
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospira, Inc.
- Date Received
- October 19, 2006
- Decision Date
- December 11, 2006
- Product Code
- IQG
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IQG | Adaptor, Holder, Syringe | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IQG), ordered by most recent decision date.
INSULIN PROTECTOR
FDA 510(k)
FDA Class 1
·Physical Medicine
INSUCOZI INSULIN VIAL COVER
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Hospira, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Mar 28, 2017 | Substantially Equivalent |
| K161036 | Hospira Extension Set, Hospira Primary Set | Jan 6, 2017 | Substantially Equivalent |
| K160492 | Hospira Sapphire Sets | Dec 6, 2016 | Substantially Equivalent |
| K160870 | Hospira Administration Sets | Jun 1, 2016 | Substantially Equivalent |
| K143612 | LifeCare PCA Infusion System | Apr 8, 2016 | Substantially Equivalent |
| K143087 | Hospira Blood Set | Mar 4, 2015 | Substantially Equivalent |
| K143015 | Hospira Primary Sets | Feb 25, 2015 | Substantially Equivalent |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | Jan 16, 2015 | Substantially Equivalent |
| K142622 | IV Administration | Jan 15, 2015 | Substantially Equivalent |
| K142974 | Extension Sets | Jan 9, 2015 | Substantially Equivalent |