← Back to catalogue

APRO 70 Swift Catheter

FDA UDI

Class II (US FDA UDI)

by Alembic Llc

Identity

Trade Name
APRO 70 Swift Catheter FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Model / Reference
FG-02133-132-AC FDA UDI

Identifiers

Catalog Number
APRO 70-132 FDA UDI
Primary DI / UDI-DI
00850014025267 FDA UDI
510(k) Number
K243287 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

No

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

APRO 70 Swift Catheter by Alembic 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

K243287 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
Alembic Llc

Sources (1)

  • FDA UDI 9c7bb012-ebd5-42d4-99ad-04a2df6451b5 35 fields · synced May 30, 2026