Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2248146

FEI Number

1000222374

Entity Name

Datascope Corp.

City/State/Country

FAIRFIELD, NJ, US

Establishment Address

15 Law Dr, FAIRFIELD, NJ 07004, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K002365

PMA Number

N/A

All Registered Proprietary Names

LINEAR 7.5Fr. IAB Catheter & Accessories SENSATION 7Fr. IAB Catheter & Accessories CS300 Intra-Aortic Balloon Pump SENSATION PLUS 7.5Fr. 40cc IAB Catheter & Accessories guidewire SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories MEGA 8Fr. 50cc IAB Catheter & Accessories STATLOCK IAB Stabilization Device introducer set

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	2007-12-18
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	2012-09-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-18
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2015-12-03
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2003-08-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	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
3007965489	Datascope Corp	Wayne, 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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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
3024894463	DOLPHIN LIFE SCIENCE (INDIA) LLP	Surat Gujarat, IN
3013162291	Arrow International LLC (subsidiary of Teleflex Incorporated)	Morrisville, NC, US
3007965489	Datascope Corp	Wayne, NJ, US
3013320573	TOKAI MEDICAL PRODUCTS	Toki-City Gifu, JP
9680794	Arrow Internacional de Chihuahua S.A. de C.V.	CHIHUAHUA, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2248146. Last updated year: 2026. Please use registration number 2248146 when referencing this establishment in official correspondence.