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BASHIR™ S-B .035 Endovascular Catheter

FDA UDI

Class II (US FDA UDI)

by Thrombolex, Inc.

Identity

Trade Name
BASHIR™ S-B .035 Endovascular Catheter FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Device Name
Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm basket FDA UDI
Model / Reference
8101 FDA UDI
Description
Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm basket FDA UDI

Identifiers

Catalog Number
8101 FDA UDI
Primary DI / UDI-DI
00850005115083 FDA UDI
510(k) Number
K231653 FDA UDI
FDA Product Code
QEY FDA UDI
KRA FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
870.1210 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

Category: Peripheral vascular intervention infusion catheter

BASHIR™ S-B .035 Endovascular Catheter by Thrombolex, 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

K231653 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thrombolex, Inc.

Sources (1)

  • FDA UDI bf24f9eb-a9f3-4847-8093-9f5f42a2477d 36 fields · synced May 31, 2026