FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K Number: K991137
·
Decision Jun 8, 2000
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
90
Applicant Total
33
Review Days
430
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Basic Information
- Device Name
- ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
- K Number
- K991137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minntech Corp.
- Date Received
- April 5, 1999
- Decision Date
- June 8, 2000
- 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 |
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