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IMPEDE-FX Embolization Plug
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref IMP-FX-08
Identity
- Trade Name
- IMPEDE-FX Embolization Plug EUDAMEDFDA UDI
- Generic Name
- Extraluminal vascular occluder, single-use FDA UDI
- Device Name
- IMPEDE-FX Embolization Plug, 8mm EUDAMEDFDA UDI
- Model / Reference
- IMP-FX-08 EUDAMEDFDA UDI
- Description
- IMPEDE-FX Embolization Plug, 8mm FDA UDI
Identifiers
- Catalog Number
- IMP-FX-08 FDA UDI
- Primary DI / UDI-DI
- 00810041650047 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810041650047 EUDAMED
- 510(k) Number
- K182390 FDA UDI
- FDA Product Code
- KRD FDA UDI
- EMDN Code
- C0104020209 PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES EUDAMED
- GMDN Term
- Extraluminal vascular occluder, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182390 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810041650047 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shape Memory Medical Inc
- EUDAMED SRN
- US-MF-000008157
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (3)
- EUDAMED 9e0dd30c-2bec-4778-a0a1-32799d702a5c 61 fields · synced Jul 9, 2026
- FDA UDI 0f82b926-b14e-40fa-9619-081a68107f2a 35 fields · synced May 30, 2026
- FDA 510(k) K182390 1 fields · synced May 18, 2026