FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
K Number: K130639
·
Decision May 16, 2013
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
44
Review Days
66
Basic Information
- Device Name
- ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
- K Number
- K130639
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAQUET CARDIOPULMONARY AG
- Date Received
- March 11, 2013
- Decision Date
- May 16, 2013
- Product Code
- DWF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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