FDA.reportPublic FDA data

Supreme™

Primary DI
05414734202084
Brand
Supreme™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
402020
Catalog number
402020
Device description
Electrophysiology Catheter
Published
2015-04-22
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

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894500000DAIG ELECTROPHYSIOLOGY CATHETERDaig Corp.1989-09-18DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734202084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734202084054147342020845414734202084

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping/radio-frequency ablation catheter, single-useA sterile, flexible, steerable catheter intended to be used as part of a cardiac mapping system and/or a radio-frequency cardiac ablation system to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping, and/or to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart, in the evaluation/treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL,DARK,DRY PLACE. Protect from radioactive sources.
Special Storage Condition, Specify00STORE IN A COOL,DARK,DRY PLACE.Protect from radioactive sources.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
040960379
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734202398Livewire™4016524016522015-02-06
05414734001052Pacel™4017664017662015-07-31
05414734001076Pacel™4017674017672015-07-31
05414734001090Pacel™4017684017682015-07-31
05414734001113Pacel™4017704017702015-07-31
05414734001137Pacel™4017714017712015-07-31
05414734001151Pacel™4017724017722015-07-31
05414734001175Pacel™4017734017732015-07-31
05414734001199Pacel™4017744017742015-07-31
05414734001212Pacel™4017754017752015-07-31
05414734001236Pacel™4017764017762015-07-31
05414734026512Pacel™4017654017652015-07-31
05414734027281Pacel™4017694017692015-07-31
05414734001045Pacel™4017624017622016-01-28
05414734007856Pacel™4017634017632016-01-28
05414734021906Pacel™4017614017612016-01-28
05414734022521Pacel™4017644017642016-01-28
05414734205153BRK™G407211G4072112015-11-13
05414734202183Livewire™4015754015752015-02-06
05414734202244Livewire™4015814015812015-02-06

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