FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
K Number: K110909
·
Decision Apr 29, 2011
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
35
Applicant Total
883
Review Days
29
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Basic Information
- Device Name
- EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
- K Number
- K110909
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- March 31, 2011
- Decision Date
- April 29, 2011
- 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 |
Similar 510(k) Clearances
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