FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
POLYSTAN HEART-LUNG MACHINE SYSTEM
K Number: K894657
·
Decision Mar 28, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
247
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Basic Information
- Device Name
- POLYSTAN HEART-LUNG MACHINE SYSTEM
- K Number
- K894657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3670
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Polystan C/O Vitalcor, Inc.
- Date Received
- July 24, 1989
- Decision Date
- March 28, 1990
- Product Code
- DJQ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJQ | Test Reagents For Phenothiazine | FDA class 2 | Clinical Toxicology |
Other Clearances by Polystan C/O Vitalcor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893940 | POLYSTAN HEATER-COOLER UNIT | Jan 18, 1990 | Substantially Equivalent |
| K893705 | SAFE-1 VENOUS RESERVOIR | Dec 22, 1989 | Substantially Equivalent |
| K893704 | SAFE-1 | Dec 22, 1989 | Substantially Equivalent |
| K874853 | POLYSTAN TWO STAGE CATHETERS | Feb 5, 1988 | Substantially Equivalent |
| K874852 | POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS | Feb 5, 1988 | Substantially Equivalent |
| K872182 | POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE | Oct 30, 1987 | Substantially Equivalent |
| K843538 | PO 2 LYTRODE | Oct 18, 1984 | Substantially Equivalent |