FDA.reportPublic FDA data

OPAL HDx™

Primary DI
00191506063146
Brand
OPAL HDx™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004OPAL65110
Catalog number
M004OPAL65110
Device description
Ablation Connection Box - (for INTELLAGEN™)
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150005088

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150005088BLAZER OPEN-IRRIGATED ABLATION CATHETERBoston Scientific Corp2016-02-24OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506063146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506063146001915060631461915060631460191506063146

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00191506063153OPAL HDx™M004OPAL63020M004OPAL630202026-10-30
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14
08714729840619SYNERGY™H7493926116400H74939261164002016-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506063153OPAL HDx™BOSTON SCIENTIFIC CORPORATIONOAD2026-10-30
00763000954345NAMEDTRONIC, INC.OAD2026-08-14
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
20763000995007N/AMEDTRONIC, INC.OAD2025-04-12
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAD2025-01-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAD2024-12-06
00763000871772NAMEDTRONIC, INC.OAD2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAD2024-11-04
20763000871776NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2024-11-04