FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K Number: K872107
·
Decision Aug 28, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
249
Applicant Total
33
Review Days
80
Basic Information
- Device Name
- WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
- K Number
- K872107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MINNTECH CORP.
- Date Received
- June 9, 1987
- Decision Date
- August 28, 1987
- 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.
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
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
FDA 510(k)
FDA Class 2
·Cardiovascular
D100 KIDS; D101 KIDS
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
FDA 510(k)
FDA Class 2
·Cardiovascular
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by MINNTECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K120306 | RAPICIDE OPA-28 | Sep 27, 2012 | Substantially Equivalent |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Apr 5, 2010 | Substantially Equivalent |
| K071298 | HF JUNIOR HEMOFILTER | Aug 8, 2007 | Substantially Equivalent |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | Jan 31, 2006 | Substantially Equivalent |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Apr 27, 2004 | Substantially Equivalent |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Feb 1, 2002 | Substantially Equivalent |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | Jun 8, 2000 | Substantially Equivalent |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | Apr 4, 2000 | Substantially Equivalent |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Aug 30, 1999 | Substantially Equivalent |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | Mar 8, 1999 | Substantially Equivalent |