Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220648

FEI Number

1220648

Entity Name

ABIOMED, INC.

City/State/Country

DANVERS, MA, US

Establishment Address

22 Cherry Hill Dr, DANVERS, MA 01923, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABIOMED, INC. (Owner Number: 1220648)

Owner / Operator Contact Address

22 CHERRY HILL DR., --, Danvers, MA 01923, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192769

PMA Number

N/A

All Registered Proprietary Names

Impella RP Impella RP with SmartAssist Impella RP Flex with SmartAssist Automated Impella Controller (AIC) Impella 2.5 Impella 5 Impella LD Impella CP Impella CP with SmartAssist Impella 5.5 with SmartAssist Low Profile Companion Sheath Abiomed 14Fr Low Profile Introducer Set Impella Connect Abiomed 23 Fr Introducer Impella CP Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump	Cardiovascular	Class 3	870.4360	2017-11-09
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2014-11-04
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump	Unknown	Class 3	N/A	2015-05-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-12-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-10-24
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2014-05-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-15
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2023-04-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-01-21

Official Correspondent

Anshul Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABIOMED, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014990448	Breethe, Inc.	Halethorpe, MD, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

Registration Number	Establishment Name	Location
3007904765	ABIOMED EUROPE GMBH	Aachen North Rhine-Westphalia, DE
3010197700	OMNI COMPONENTS CORPORATION	Hudson, NH, US
3023190433	CARDIOPRECISION LTD	Glasgow Lancashire, GB
1530504	RULTRACT INC	Independence, OH, US
1058584	Sterigenics US LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220648. Last updated year: 2026. Please use registration number 1220648 when referencing this establishment in official correspondence.