FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GELBFISH ENDO-VAC SYSTEM
K Number: K970233
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
1
Review Days
260
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Basic Information
- Device Name
- GELBFISH ENDO-VAC SYSTEM
- K Number
- K970233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Gary A. Gelbfish
- Date Received
- January 21, 1997
- Decision Date
- October 8, 1997
- Product Code
- MCW
- 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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