FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
K Number: K201867
·
Decision Nov 19, 2020
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
61
Review Days
135
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Basic Information
- Device Name
- Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
- K Number
- K201867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corporation
- Date Received
- July 7, 2020
- Decision Date
- November 19, 2020
- Product Code
- FKX
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
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