FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOHELP SYSTEM
K Number: K133598
·
Decision May 21, 2014
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
51
Applicant Total
44
Review Days
180
Basic Information
- Device Name
- CARDIOHELP SYSTEM
- K Number
- K133598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAQUET CARDIOPULMONARY AG
- Date Received
- November 22, 2013
- Decision Date
- May 21, 2014
- Product Code
- DTQ
- 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 |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by MAQUET CARDIOPULMONARY AG
| K Number | Device Name | ||
|---|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | May 7, 2015 | Substantially Equivalent |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | Nov 19, 2014 | Substantially Equivalent |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | Jul 7, 2014 | Substantially Equivalent |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | Nov 12, 2013 | Substantially Equivalent |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | Oct 30, 2013 | Substantially Equivalent |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | Oct 8, 2013 | Substantially Equivalent |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | Jul 5, 2013 | Substantially Equivalent |
| K130300 | HEATER-COOLER UNIT HCU 40 | Jul 1, 2013 | Substantially Equivalent |
| K123288 | HEMOCONCENTRATOR | Jun 26, 2013 | Substantially Equivalent |
| K130639 | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER | May 16, 2013 | Substantially Equivalent |