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Sleek PTA Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by ClearStream Technologies , Ltd.

Identity

Trade Name
Sleek PTA Dilatation Catheter FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
Sleek PTA Dilatation Catheter 2.0mm x 180mm balloon, 155cm shaft FDA UDI
Model / Reference
425-2018X FDA UDI
Description
Sleek PTA Dilatation Catheter 2.0mm x 180mm balloon, 155cm shaft FDA UDI

Identifiers

Catalog Number
425-2018X FDA UDI
Primary DI / UDI-DI
00801741132285 FDA UDI
510(k) Number
K072947 FDA UDI
FDA Product Code
LIT 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

Sleek PTA Dilatation Catheter by ClearStream Technologies , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K072947 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ClearStream Technologies , Ltd.

Sources (1)

  • FDA UDI f55f5ce2-7bdf-4e40-934f-c6fdda17c838 38 fields · synced May 30, 2026