FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
K Number: K100364
·
Decision Nov 3, 2010
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
13
Review Days
264
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Basic Information
- Device Name
- GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
- K Number
- K100364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gambro Renal Products, Inc.
- Date Received
- February 12, 2010
- Decision Date
- November 3, 2010
- Product Code
- FJK
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
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| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Jul 29, 2010 | Substantially Equivalent |
| K080519 | PRISMAFLEX M150 SET | Jun 13, 2008 | Substantially Equivalent |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Sep 7, 2007 | Substantially Equivalent |