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Impella

FDA UDI

Class II (US FDA UDI)

by Abiomed, Inc.

Identity

Trade Name
Impella FDA UDI
Generic Name
Intracardiac circulatory assist axial-pump catheter FDA UDI
Device Name
KIT, 14Fr INTRODUCER, 13 cm, ABMD FDA UDI
Model / Reference
0052-3057 FDA UDI
Description
KIT, 14Fr INTRODUCER, 13 cm, ABMD FDA UDI

Identifiers

Catalog Number
0052-3057 FDA UDI
Primary DI / UDI-DI
00813502011654 FDA UDI
510(k) Number
K192769 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Intracardiac circulatory assist axial-pump catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intracardiac circulatory assist axial-pump catheter

Impella by Abiomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac circulatory assist axial-pump catheter.

Cleared under the same submission

K192769 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abiomed, Inc.

Sources (1)

  • FDA UDI 2549d130-3efd-4a35-a614-1fd5183f975e 35 fields · synced May 30, 2026