FDA.reportPublic FDA data

Woven

Primary DI
08714729899051
Brand
Woven
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004200204E0
Device description
Diagnostic Electrode Catheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729899051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729899051087147298990518714729899051

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA 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, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
00763000719272NAMEDTRONIC, INC.DRF2024-08-22
00763000719289NAMEDTRONIC, INC.DRF2024-08-22
00763000719296NAMEDTRONIC, INC.DRF2024-08-22
00763000719302NAMEDTRONIC, INC.DRF2024-08-22
00763000443214NAMEDTRONIC, INC.DRF2024-05-18
00763000465728NAMEDTRONIC, INC.DRF2024-05-18
06952450918999EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919002EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919019EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942598EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942611EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942628EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942635EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952221EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952238EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952245EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952252EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952269EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952276EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952283EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952290EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952306EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952313EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952320EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21