FDA.reportPublic FDA data

IntellaNav StablePoint™ Cable

Primary DI
00191506020408
Brand
IntellaNav StablePoint™ Cable
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004RARC040
Catalog number
M004RARC040
Device description
Catheter Cable
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150005074

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150005074BLAZER OPEN-IRRIGATED ABLATION CATHETERBoston Scientific Corp2016-02-24OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506020408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506020408001915060204081915060204080191506020408

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Centimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAE2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
05415067051943N/AST. JUDE MEDICAL, INC.OAE2025-10-31
05415067051950TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067051998TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052018TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052025TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052056TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052063TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052216TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29