FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERF-GEN PULSATILE PERFUSION SOLUTION
K Number: K121736
·
Decision Aug 16, 2013
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
18
Applicant Total
3
Review Days
429
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Basic Information
- Device Name
- PERF-GEN PULSATILE PERFUSION SOLUTION
- K Number
- K121736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Waters Medical Systems, LLC
- Date Received
- June 13, 2012
- Decision Date
- August 16, 2013
- Product Code
- KDL
- 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 |
|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | FDA class 2 | Gastroenterology, Urology |
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