FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROMEDICS BLOOD HEAT EXCHANGER
K Number: K934355
·
Decision Dec 3, 1993
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
90
Applicant Total
41
Review Days
87
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
- ELECTROMEDICS BLOOD HEAT EXCHANGER
- K Number
- K934355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electromedics, Inc.
- Date Received
- September 7, 1993
- Decision Date
- December 3, 1993
- Product Code
- DTR
- 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 |
|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTR), ordered by most recent decision date.
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
FDA 510(k)
FDA Class 2
·Cardiovascular
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
FDA 510(k)
FDA Class 2
·Cardiovascular
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Electromedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934964 | ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR | Mar 7, 1994 | Substantially Equivalent |
| K933832 | ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR | Jan 28, 1994 | Substantially Equivalent |
| K930154 | EL2-SERIES BLOOD COLLECTION REERVOIR | Jul 1, 1993 | Substantially Equivalent |
| K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR | Feb 19, 1993 | Substantially Equivalent |
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | Feb 5, 1993 | Substantially Equivalent |
| K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR | Sep 3, 1992 | Substantially Equivalent |
| K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 | Jun 19, 1991 | Substantially Equivalent |
| K910935 | MODIFIED PYROGEN TESTING | May 16, 1991 | Substantially Equivalent |
| K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 | Dec 13, 1990 | Substantially Equivalent |
| K903392 | ELECTROMEDICS BT422-120 AND BT422-40 | Sep 6, 1990 | Substantially Equivalent |