FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUADEX SYSTEM 100, MODEL A1100
K Number: K040489
·
Decision Apr 27, 2004
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
13
Review Days
61
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Basic Information
- Device Name
- AQUADEX SYSTEM 100, MODEL A1100
- K Number
- K040489
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chf Solutions, Inc.
- Date Received
- February 26, 2004
- Decision Date
- April 27, 2004
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Chf Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192756 | Aquadex FlexFlow System 2.0 | Feb 24, 2020 | Substantially Equivalent |
| K071854 | AQUADEX FLEXFLOW SYSTEM | Sep 7, 2007 | Substantially Equivalent |
| K070512 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | Apr 27, 2007 | Substantially Equivalent |
| K062922 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | Dec 13, 2006 | Substantially Equivalent |
| K060008 | AQUADEX FLEXFLOW SYSTEM | Feb 2, 2006 | Substantially Equivalent |
| K050609 | AQUADEX SYSTEM | Nov 9, 2005 | Substantially Equivalent |
| K041791 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Sep 10, 2004 | Substantially Equivalent |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Dec 23, 2003 | Substantially Equivalent |
| K023874 | SYSTEM 100 ULTRAFILTRATION CATHETER | Nov 20, 2003 | Substantially Equivalent |
| K024124 | SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT | Mar 14, 2003 | Substantially Equivalent |