Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007965489

FEI Number

3007965489

Entity Name

Datascope Corp

City/State/Country

Wayne, NJ, US

Establishment Address

45 Barbour Pond Drive, Wayne, NJ 07470, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories MEGA 8Fr. 50cc IAB Catheter & Accessories CS300 CS100/CS100i CARDIOSAVE Li-Ion Battery Transport and Storage Case CARDIOSAVE Rescue Intra-Aortic Balloon Pump SENSATION 7Fr. IAB Catheter & Accessories CS300 Intra-Aortic Balloon Pump Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) LINEAR 7.5Fr. IAB Catheter & Accessories

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	2012-09-18
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	2024-02-06
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	2011-10-20
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-12-06
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	2007-12-18

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
2249723	Datascope Corp.	MAHWAH, 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-05	Datascope Corp	2	Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

Similar Registrations

Registration Number	Establishment Name	Location
3024894463	DOLPHIN LIFE SCIENCE (INDIA) LLP	Surat Gujarat, IN
3013162291	Arrow International LLC (subsidiary of Teleflex Incorporated)	Morrisville, NC, US
3013320573	TOKAI MEDICAL PRODUCTS	Toki-City Gifu, JP
9680794	Arrow Internacional de Chihuahua S.A. de C.V.	CHIHUAHUA, MX
3010532612	Arrow International, LLC (subsidiary of Teleflex, Incorporated)	Chelmsford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007965489. Last updated year: 2026. Please use registration number 3007965489 when referencing this establishment in official correspondence.