FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Needle's Eye Snare Retrieval Set - 54cm
K Number: K163353
·
Decision Jul 11, 2017
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
175
Review Days
223
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Basic Information
- Device Name
- Needle's Eye Snare Retrieval Set - 54cm
- K Number
- K163353
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- November 30, 2016
- Decision Date
- July 11, 2017
- 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 |
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