FDA.reportPublic FDA data

N/A

Primary DI
00885825005931
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
401273
Device description
Diagnostic EP Catheter JSN Curve, 6 electrodes, 2-5-2-5-2mm spacing, 6F
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
NLHCatheter, Recording, Electrode, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030026000REPROCESSED ELECTROPHYSIOLOGY CATHETERAlliance Medical Corp.2003-05-02NLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885825005931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885825005931008858250059318858250059310885825005931

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, reprocessedA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327666878N/ALXMJ23LLXMJ23L2026-06-25
07613327666885N/ALXMJ23SLXMJ23S2026-06-25
07613327666892N/ALXMJ44SLXMJ44S2026-06-25
07613327666908N/ALXMJ37SLXMJ37S2026-06-25
07613327666915N/ALXMJ44LLXMJ44L2026-06-25
07613327666922N/ALXMJ37LLXMJ37L2026-06-25
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28