FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PALINDROME P HEMODIALYSIS CATHETER
K Number: K092205
·
Decision Oct 30, 2009
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
3
Review Days
100
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Basic Information
- Device Name
- PALINDROME P HEMODIALYSIS CATHETER
- K Number
- K092205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Covidien Lp, Formerly Registered AS Kendall
- Date Received
- July 22, 2009
- Decision Date
- October 30, 2009
- Product Code
- MSD
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
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