FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K Number: K161504
·
Decision Jan 6, 2017
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
37
Applicant Total
175
Review Days
219
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Basic Information
- Device Name
- Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
- K Number
- K161504
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- June 1, 2016
- Decision Date
- January 6, 2017
- Product Code
- MPB
- 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 |
|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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