FDA.reportPublic FDA data

HELIOS

Primary DI
00836559006640
Brand
HELIOS
Company
Oscor Inc.
Model
H05110U
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LDFElectrode, Pacemaker, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072770000TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)Oscor, Inc.2008-01-22LDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836559006640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836559006640008365590066408365590066400836559006640

GMDN Terms#

Term, Definition table
TermDefinition
Atrial cardioversion system catheterA sterile, thin, flexible tube that interfaces proximally with an electrocardiogram (ECG) monitor/recorder and defibrillator, and distally with the myocardium, for electrical cardioversion (CV) to treat atrial tachyarrhythmias [e.g., atrial fibrillation (AF)]. It typically has multiple lumens with specific functions (e.g., for various electrode arrays, guidewire, air) and may be balloon-tipped to facilitate transvenous placement; it may have sensing, pacing, and pressure measurement capabilities. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101835833
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502010237Introducer Kit for Impella®0052-30140052-30142017-11-18
00813502010244Introducer Kit for Impella®0052-30150052-30152017-11-18
00813502010558Introducer Kit for Impella®0052-30210052-30212017-11-18
00813502010664Introducer Kit for Impella®0052-30250052-30252017-11-30
00813502011517Introducer Kit for Impella®0052-30010052-30012017-11-30
00813502011562Introducer Kit for Impella®0052-30000052-30002017-11-30
00813502011609Introducer Kit for Impella®0052-30060052-30062017-11-19
00885672013226VV-Plug667145-303VV-PLUG2026-06-01
00885672013233LV-1 Plug667147-303LV-1 PLUG2026-06-01
00885672013240IS4/DF4 Plug667148-303IS4/DF4 PLUG2026-06-01
00885672012892Volante™VLT-6.5-45-9-SVLT-6.5-45-9-S2026-05-08
00885672012908Volante™VLT-6.5-45-17-SVLT-6.5-45-17-S2026-05-08
00885672012915Volante™VLT-6.5-55-7-S-SDVLT-6.5-55-7-S-SD2026-05-08
00885672012922Volante™VLT-6.5-55-9-SVLT-6.5-55-9-S2026-05-08
00885672012939Volante™VLT-6.5-55-9-S-PFVLT-6.5-55-9-S-PF2026-05-08
00885672012946Volante™VLT-6.5-55-17-SVLT-6.5-55-17-S2026-05-08
00885672012953Volante™VLT-6.5-90-9-SVLT-6.5-90-9-S2026-05-08
00885672012960Volante™VLT-7-45-9-SVLT-7-45-9-S2026-05-08
00885672012977Volante™VLT-7-45-17-SVLT-7-45-17-S2026-05-08
00885672012984Volante™VLT-7-55-9-SVLT-7-55-9-S2026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
10801902216110ARROWTELEFLEX INCORPORATEDLDF2023-07-14
10801902198386ARROWTELEFLEX INCORPORATEDLDF2022-11-18
08718627412701MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2016-04-25
08718627411674MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411698MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411711MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411735MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411759MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411773MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411797MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411810MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411834MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411858MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411872MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411896MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411919MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411933MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411957MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411971MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411995MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412015MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412039MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412053MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412077MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412091MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412114MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412138MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412152MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412176MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11