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Sniper

FDA UDI

Class II (US FDA UDI)

by Embolx, Inc.

Identity

Trade Name
Sniper FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Device Name
The Sniper is a dual lumen, 165cm, 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-165 FDA UDI
Description
The Sniper is a dual lumen, 165cm, 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-165 FDA UDI
Primary DI / UDI-DI
00853359008414 FDA UDI
510(k) Number
K180904 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
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

Dimensions & Sizes

Size
Catheter Working Length — 165 Centimeter FDA UDI

Category: Peripheral vascular intervention infusion catheter

Sniper by Embolx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular intervention infusion catheter.

Cleared under the same submission

K180904 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Embolx, Inc.

Sources (1)

  • FDA UDI d0819543-2775-4fa0-9a21-f72b36e60013 36 fields · synced May 31, 2026