FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K Number: K193379
·
Decision Jun 12, 2020
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
136
Review Days
190
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Basic Information
- Device Name
- Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
- K Number
- K193379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- December 5, 2019
- Decision Date
- June 12, 2020
- Product Code
- DXE
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXE), ordered by most recent decision date.
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