FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-CHEK ULTRAFLEX INFUSION SET
K Number: K070189
·
Decision Feb 21, 2007
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- ACCU-CHEK ULTRAFLEX INFUSION SET
- K Number
- K070189
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Disetronic Medical Systems AG
- Date Received
- January 22, 2007
- Decision Date
- February 21, 2007
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Disetronic Medical Systems AG
| K Number | Device Name | ||
|---|---|---|---|
| K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE | May 14, 2010 | Substantially Equivalent |
| K063146 | ACCU-CHEK LINKASSIST | Nov 27, 2006 | Substantially Equivalent |
| K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA | Jun 15, 2006 | Substantially Equivalent |
| K042887 | ACCU-CHEK SPIRIT | Mar 18, 2005 | Substantially Equivalent |
| K043000 | MODIFICATION TO D-TRONPLUS | Dec 1, 2004 | Substantially Equivalent |
| K033892 | ULTRAFLEX INFUSION SET | Mar 9, 2004 | Substantially Equivalent |
| K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP | Oct 29, 2002 | Substantially Equivalent |
| K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP | Sep 11, 2002 | Substantially Equivalent |
| K021725 | DISETRONIC D-TRON INSULIN INFUSION PUMP | Aug 2, 2002 | Substantially Equivalent |
| K003977 | DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET | Feb 15, 2001 | Substantially Equivalent |