FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Firefly Peritoneal Dialysis Connector Disinfection System
K Number: K151620
·
Decision Jan 20, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
3
Review Days
218
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Basic Information
- Device Name
- Firefly Peritoneal Dialysis Connector Disinfection System
- K Number
- K151620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Puracath Medical, Inc.
- Date Received
- June 16, 2015
- Decision Date
- January 20, 2016
- Product Code
- KDJ
- 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | FDA class 2 | Gastroenterology, Urology |
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