FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDOS HILITE OXYGENATOR
K Number: K140177
·
Decision Feb 18, 2014
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
3
Review Days
25
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDOS HILITE OXYGENATOR
- K Number
- K140177
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos Medizintechnik AG
- Date Received
- January 24, 2014
- Decision Date
- February 18, 2014
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTZ), ordered by most recent decision date.
Lifemotion Disposable Membrane Oxygenator
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
FDA 510(k)
FDA Class 2
·Cardiovascular
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
FDA 510(k)
FDA Class 2
·Cardiovascular
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
FDA 510(k)
FDA Class 2
·Cardiovascular
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
FDA 510(k)
FDA Class 2
·Cardiovascular