Sniper Infusion Catheter with Balloon Occlusion
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Embolx, Inc.
Identity
- Trade Name
- Sniper EUDAMEDFDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- Sniper Balloon Occlusion Microcatheter EUDAMEDThe Sniper is a dual lumen, 130cm, straight 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-STR-130 EUDAMEDFDA UDI
- Description
- The Sniper is a dual lumen, 130cm, straight 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-STR-130 FDA UDI
- Primary DI / UDI-DI
- 00853359008049 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00853359008049 EUDAMED
- 510(k) Number
- FDA Product Code
- MJN FDA 510(k)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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 130 Centimeter FDA UDI
The Sniper Infusion Catheter with Balloon Occlusion is an intravascular, temporary occluding catheter designed for selective vascular access and occlusion. It combines infusion capabilities with a balloon mechanism to isolate targeted vascular segments, enabling precise delivery of therapeutic agents or embolic materials while maintaining flow control in complex or distal vessels.
This device is intended for use in interventional radiology and cardiology procedures, supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulations (870.4450) and has received FDA 510(k) clearance and MDD authorization. Available in multiple reference codes (e.g., 1721676, 3026788751), the catheter is designed for MRI safety where applicable and must be stored as directed to preserve sterility and functionality.
Frequently asked questions
What types of medical procedures is the Sniper Infusion Catheter with Balloon Occlusion primarily used for?
The Sniper Infusion Catheter with Balloon Occlusion is designed for use in interventional radiology and cardiology procedures, where precise vascular access and occlusion are required. Its dual functionality—combining infusion capabilities with a balloon mechanism—allows clinicians to isolate targeted vascular segments, enabling controlled delivery of therapeutic agents or embolic materials in complex or distal vessels.
Is the Sniper Infusion Catheter with Balloon Occlusion intended for reuse, or is it single-use only?
The device is intended for single-use only, as explicitly stated in its description. It is supplied sterile, and reuse is not recommended to maintain safety and efficacy.
How should the Sniper Infusion Catheter with Balloon Occlusion be stored to ensure sterility and functionality?
The device must be stored as directed by the manufacturer to preserve sterility and functionality. While specific storage instructions are not detailed in the provided data, standard sterile medical device storage practices (e.g., sealed packaging, protected from contamination) should be followed to avoid compromising its performance.
Does the Sniper Infusion Catheter with Balloon Occlusion have MRI compatibility, and if so, for which models?
The device is designed for MRI safety where applicable, though the exact models or configurations compatible with MRI are not specified in the provided data. Clinicians should verify MRI compatibility with the manufacturer’s documentation or labeling before use in an MRI environment.
What regulatory pathways has the Sniper Infusion Catheter with Balloon Occlusion undergone, and how does this affect its classification?
The device has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. It is classified as a Class II medical device under FDA regulations (870.4450), indicating it has undergone a higher level of scrutiny than Class I devices but does not require the same rigorous premarket approval process as Class III devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sniper® Balloon Occlusion Microcatheter | Embolx, Embolx | Sniper Balloon Microcatheter, Sniper | Siemens Healthineers | Cancer Care, Sniper Infusion Catheter with Balloon Occlusion (K180904) — FDA 510(k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180904 | Class II | Active |
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Manufacturer
- Manufacturer
- Embolx, Inc.
Sources (3)
- FDA 510(k) K180904 24 fields · synced Sep 18, 2026
- FDA UDI 7919f0ac-152f-4022-a6cd-c79893b8973e 36 fields · synced May 30, 2026
- EUDAMED ffca4f9e-e132-4d30-8c67-cdd2ce7f4eca 61 fields · synced Jul 19, 2026