Identity
- Trade Name
- IMPEDE-FX Embolization Plug FDA UDI
- Generic Name
- Extraluminal vascular occluder, single-use FDA UDI
- Device Name
- IMPEDE-FX Embolization Plug 6mm FDA UDI
- Model / Reference
- IMP-FX-06 FDA UDI
- Description
- IMPEDE-FX Embolization Plug 6mm FDA UDI
Identifiers
- Catalog Number
- IMP-FX-06 FDA UDI
- Primary DI / UDI-DI
- B054IMPFX061 FDA UDI
- 510(k) Number
- K182390 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Extraluminal vascular occluder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
IMPEDE-FX Embolization Plug by Shape Memory Medical Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K182390 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shape Memory Medical Inc
Sources (2)
- FDA UDI be29935b-c4a0-4ff5-91b7-fc97184cab7c 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026