FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBING PACK, EXTRACORPOREAL, H-3000
K Number: K770720
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
3
Review Days
108
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Basic Information
- Device Name
- TUBING PACK, EXTRACORPOREAL, H-3000
- K Number
- K770720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- William Harvey Life Products Corp.
- Date Received
- April 18, 1977
- Decision Date
- August 4, 1977
- Product Code
- BYS
- 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 |
|---|---|---|---|
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | FDA class 2 | Cardiovascular |
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