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Raptor Aspiration Catheter

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
Raptor Aspiration Catheter FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Raptor Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Raptor Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The distal tip of the catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Raptor Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters. FDA UDI
Model / Reference
RPTR071140 FDA UDI
Description
The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Raptor Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Raptor Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The distal tip of the catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Raptor Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters. FDA UDI

Identifiers

Primary DI / UDI-DI
00840303713524 FDA UDI
510(k) Number
K234083 FDA UDI
FDA Product Code
NRY FDA UDI
GMDN Term
Thrombectomy suction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

Yes

FDA UDI

Category: Thrombectomy suction catheter

Raptor Aspiration Catheter by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy suction catheter.

Cleared under the same submission

K234083 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Balt Usa Llc

Sources (1)

  • FDA UDI 030490e3-a09f-468d-bba8-85233c45dc3e 36 fields · synced May 30, 2026