Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2249723

FEI Number

3001418283

Entity Name

Datascope Corp.

City/State/Country

MAHWAH, NJ, US

Establishment Address

1300 Macarthur Blvd, MAHWAH, NJ 07430, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Datascope Corp. (Owner Number: 2221819)

Owner / Operator Contact Address

45 Barbour Pond Drive, Wayne, NJ 07470, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172305

PMA Number

N/A

All Registered Proprietary Names

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) CARDIOSAVE Li-Ion Battery Transport and Storage Case CS300 CS100/CS100i

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2015-12-03
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2020-08-18
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2024-02-06
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2024-02-06

Official Correspondent

Elliott Jang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Datascope Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007965489	Datascope Corp	Wayne, NJ, US
2248146	Datascope Corp.	FAIRFIELD, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903893	Datascope Corp.	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249723. Last updated year: 2026. Please use registration number 2249723 when referencing this establishment in official correspondence.