FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VACUUM ASSIST STABILIZER
K Number: K992833
·
Decision Nov 10, 1999
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
3
Applicant Total
3
Review Days
79
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Basic Information
- Device Name
- VACUUM ASSIST STABILIZER
- K Number
- K992833
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardio Thoracic Systems
- Date Received
- August 23, 1999
- Decision Date
- November 10, 1999
- Product Code
- MWS
- 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 |
|---|---|---|---|
| MWS | Stabilizer, Heart | FDA class 1 | Cardiovascular |
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