FDA.reportPublic FDA data

C2 CryoBalloon

Primary DI
00854924006187
Brand
C2 CryoBalloon
Company
C2 THERAPEUTICS, INC.
Model
FG-1018
Catalog number
FG-1018
Device description
Foot Pedal
Published
2018-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160994000C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc.2016-05-19GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854924006187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854924006187008549240061878549240061870854924006187

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929139249
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006064Controller, Full/SwipeFG-1006FG-10062016-10-19
00854924006088Catheter, Full, StandardFG-1008FG-10082016-10-19
00854924006095C2 CryoBalloon Focal Catheter, StandardFG-1009FG-10092016-10-19
00854924006125C2 CryoBalloon Focal ControllerFG-1012FG-10122016-10-19
00854924006156C2 CryoBalloon Swipe Catheter, StandardFG-1015FG-10152016-10-19
00854924006248C2 CryoBalloonFG-1024FG-10242018-03-26
00854924006262C2 CryoBalloonFG-1026FG-10262018-03-26
00854924006279C2 CryoBalloonFG-1027FG-10272018-03-26
00854924006286C2 CryoBalloonFG-1028FG-10282018-03-08
00854924006309C2 CryoBalloonFG-1030FG-10302018-03-08
00854924006316C2 CryoBalloonFG-1031FG-10312018-03-08
00854924006323C2 CryoBalloon Full 8 CatheterFG-1032FG-10322016-10-19
00854924006330C2 CryoBalloon Focal Pear Catheter FG-1033FG-10332016-10-19
00854924006101C2 CryoBalloon Cartridge, RegularFG-1010FG-10102016-10-19
00854924006132C2 CryoBalloon Cartridge, LargeFG-1013FG-10132016-10-19
00854924006170C2 CryoBalloonFG-1017FG-10172018-03-08
00854924006118Sidecar External Working ChannelFG-1011FG-10112016-10-19
00854924006163BOA Endoscopic ValveFG-1016FG-10162016-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28