Identity
- Trade Name
- Sniper EUDAMEDSniper® FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- Sniper Balloon Occlusion Microcatheter with K-tip EUDAMEDThe Sniper is a dual lumen, 130cm, angled tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon. FDA UDI
- Model / Reference
- SBC0629-KTP-130 EUDAMEDFDA UDI
- Description
- The Sniper is a dual lumen, 130cm, angled tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon. FDA UDI
Identifiers
- Catalog Number
- SBC0629-KTP-130 FDA UDI
- Primary DI / UDI-DI
- 00853359008070 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00853359008070 EUDAMED
- 510(k) Number
- K180904 FDA UDI
- FDA Product Code
- MJN FDA UDI
- EMDN Code
- C01050202 PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS EUDAMED
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Length — 130 Centimeter FDA UDI
Sniper by Embolx, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00853359008070 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Embolx, Inc.
- EUDAMED SRN
- US-MF-000025650
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 65868761-f180-47a1-9f92-476f4b48892e 61 fields · synced Jul 9, 2026
- FDA UDI 02735b92-217b-42c5-b44f-1278bf9687b1 36 fields · synced May 30, 2026