← Back to catalogue

Tersus -14 BTK

FDA UDI

Class II (US FDA UDI)

by Creagh Medical

Identity

Trade Name
Tersus -14 BTK FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
Tersus-14 BTK2080L 2mm x 80mm x 150cm FDA UDI
Model / Reference
BTK2080L FDA UDI
Description
Tersus-14 BTK2080L 2mm x 80mm x 150cm FDA UDI

Identifiers

Primary DI / UDI-DI
05391518031101 FDA UDI
510(k) Number
K102645 FDA UDI
FDA Product Code
LIT FDA UDI
DQY FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
Not 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
Length — 80 Millimeter FDA UDI
Outer Diameter — 2.0 Millimeter FDA UDI

Tersus -14 BTK by Creagh Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102645 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Creagh Medical

Sources (1)

  • FDA UDI 962ccf83-dfb5-4036-a1c5-4d762b06c9b7 36 fields · synced May 31, 2026