FDA.reportPublic FDA data

Giranel Guiding Sheath Set

Primary DI
06954615626572
Brand
Giranel Guiding Sheath Set
Company
Kossel Medtech (Suzhou) Co., Ltd.
Model
KSI-4.0-35-50-S2-C
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262674000Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.2026-10-15DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954615626572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954615626572069546156265726954615626572

Regulatory Flags#

DUNS number
560219894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
06954615625766Giranel Guiding Sheath SetKSI-4.0-35-70-S2-C2026-11-04
06954615626589Giranel Guiding Sheath SetKSI-4.0-35-90-S2-C2026-11-04
06954615626596Giranel Guiding Sheath SetKSI-4.0-35-110-S2-C2026-11-04
06954615626602Giranel Guiding Sheath SetKSI-5.0-35-45-S1-C2026-11-04
06954615602972Falspeed PTA Balloon Dilatation CatheterKPTA20300L2026-05-06
06954615603917Falspeed PTA Balloon Dilatation CatheterKPTA25100S2026-05-06
06954615603924Falspeed PTA Balloon Dilatation CatheterKPTA25120S2026-05-06
06954615603931Falspeed PTA Balloon Dilatation CatheterKPTA25150S2026-05-06
06954615603948Falspeed PTA Balloon Dilatation CatheterKPTA25200S2026-05-06
06954615603955Falspeed PTA Balloon Dilatation CatheterKPTA25250S2026-05-06
06954615603962Falspeed PTA Balloon Dilatation CatheterKPTA25300S2026-05-06
06954615603979Falspeed PTA Balloon Dilatation CatheterKPTA30020S2026-05-06
06954615603986Falspeed PTA Balloon Dilatation CatheterKPTA30030S2026-05-06
06954615603993Falspeed PTA Balloon Dilatation CatheterKPTA30040S2026-05-06
06954615604006Falspeed PTA Balloon Dilatation CatheterKPTA30060S2026-05-06
06954615604013Falspeed PTA Balloon Dilatation CatheterKPTA30080S2026-05-06
06954615604020Falspeed PTA Balloon Dilatation CatheterKPTA30100S2026-05-06
06954615604037Falspeed PTA Balloon Dilatation CatheterKPTA30120S2026-05-06
06954615604044Falspeed PTA Balloon Dilatation CatheterKPTA30150S2026-05-06
06954615604051Falspeed PTA Balloon Dilatation CatheterKPTA30200S2026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450839355Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-04
06954615625766Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626589Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626596Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626602Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
00884450838228Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-03
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24