FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPEDE-FX Embolization Plug
K Number: K182390
·
Decision May 23, 2019
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
2
Review Days
261
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Basic Information
- Device Name
- IMPEDE-FX Embolization Plug
- K Number
- K182390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shape Memory Medical
- Date Received
- September 4, 2018
- Decision Date
- May 23, 2019
- Product Code
- KRD
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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Other Clearances by Shape Memory Medical
| K Number | Device Name | ||
|---|---|---|---|
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | Jun 22, 2018 | Substantially Equivalent |