CorPassTM Introducer Sheath Set

Primary DI
06974949030623
Brand
CorPassTM Introducer Sheath Set
Company
Cardiocycle Medical (Suzhou) Co., Ltd
Model
CPSH1633
Device description
The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.
Published
2026-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K254248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254248000Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.2026-04-23DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974949030623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974949030623069749490306236974949030623

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Introducer Sheath Compatibilit0
Length0

Regulatory Flags#

DUNS number
725618796
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
06974949030500CorPassTM Introducer Sheath SetCPSH12332026-08-11
06974949030517CorPassTM Introducer Sheath SetCPSH12452026-08-11
06974949030524CorPassTM Introducer Sheath SetCPSH12652026-08-11
06974949030531CorPassTM Introducer Sheath SetCPSH13332026-08-11
06974949030548CorPassTM Introducer Sheath SetCPSH13452026-08-11
06974949030555CorPassTM Introducer Sheath SetCPSH13652026-08-11
06974949030562CorPassTM Introducer Sheath SetCPSH14332026-08-11
06974949030579CorPassTM Introducer Sheath SetCPSH14452026-08-11
06974949030586CorPassTM Introducer Sheath SetCPSH14652026-08-11
06974949030593CorPassTM Introducer Sheath SetCPSH15332026-08-11
06974949030609CorPassTM Introducer Sheath SetCPSH15452026-08-11
06974949030616CorPassTM Introducer Sheath SetCPSH15652026-08-11
06974949030630CorPassTM Introducer Sheath SetCPSH16452026-08-11
06974949030647CorPassTM Introducer Sheath SetCPSH16652026-08-11
06974949030654CorPassTM Introducer Sheath SetCPSH17332026-08-20
06974949030661CorPassTM Introducer Sheath SetCPSH17452026-08-20
06974949030678CorPassTM Introducer Sheath SetCPSH17652026-08-20
06974949030685CorPassTM Introducer Sheath SetCPSH18332026-08-20
06974949030692CorPassTM Introducer Sheath SetCPSH18452026-08-20
06974949030708CorPassTM Introducer Sheath SetCPSH18652026-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
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
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24