FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K Number: K081549
·
Decision Aug 19, 2008
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
857
Review Days
77
Basic Information
- Device Name
- RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
- K Number
- K081549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- June 3, 2008
- Decision Date
- August 19, 2008
- Product Code
- NTE
- 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 |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | FDA class 2 | Cardiovascular |
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