FDA.reportPublic FDA data

CircuCool™ 8005 Pump

Primary DI
08714729454816
Brand
CircuCool™ 8005 Pump
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0048005R0
Device description
Model 8005 Pump
Published
2016-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPBCardiac ablation percutaneous catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980003000
P980003001
P980003002
P980003004
P980003005
P980003007
P980003008
P980003009
P980003010
P980003013
P980003015
P980003016
P980003018
P980003019
P980003021
P980003024
P980003025
P980003027
P980003028
P980003030
P980003031
P980003034
P980003038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980003000CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003001CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003002CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003004CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003005CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003007CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003008CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003009CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003010CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003013CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003015CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003016CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003018CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003019CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003021CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003024CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003025CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003027CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003028CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003030CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003031CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003034CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB
P980003038CHILLI COOLED RF ABLATION SYSTEMBoston Scientific Corp1999-02-02LPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729454816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729454816087147294548168714729454816

GMDN Terms#

Term, Definition table
TermDefinition
Basic roller pumpA mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
04044508136959MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137031iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONLPB2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHLPB2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHLPB2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHLPB2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHLPB2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHLPB2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHLPB2024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)Stockert GmbHLPB2024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)Stockert GmbHLPB2024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)Stockert GmbHLPB2024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)Stockert GmbHLPB2024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)Stockert GmbHLPB2024-09-01
04260166374063INTELLAGEN™ RF GeneratorStockert GmbHLPB2024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbHLPB2024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbHLPB2024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbHLPB2024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbHLPB2024-09-01
00763000719265NAMEDTRONIC, INC.LPB2024-08-22
00763000719319NAMEDTRONIC, INC.LPB2024-08-22
00763000593889NAMEDTRONIC, INC.LPB2024-02-17