FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI
K Number: K832124
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
11
Review Days
43
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Basic Information
- Device Name
- CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI
- K Number
- K832124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Med-West, Inc.
- Date Received
- June 30, 1983
- Decision Date
- August 12, 1983
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Med-West, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880877 | CONTRAST INJECTION DEVICE | May 31, 1988 | Substantially Equivalent |
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| K872724 | SHEATH/DILATORS | Sep 15, 1987 | Substantially Equivalent |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Jan 3, 1986 | Unknown |
| K852162 | MNI 400 INJECTION CAPS | Jun 12, 1985 | Substantially Equivalent |
| K842342 | MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN | Jun 14, 1984 | Unknown |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Jul 7, 1983 | Substantially Equivalent |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Jun 3, 1983 | Substantially Equivalent |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Jun 3, 1983 | Substantially Equivalent |