FDA.reportPublic FDA data

SSPC NXT Delivery Catheter

Primary DI
00810024671953
Brand
SSPC NXT Delivery Catheter
Company
CENTERPOINT SYSTEMS LLC
Model
9293
Device description
Catheter and Dilator
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243180000SSPC NXT Delivery CatheterCenterPoint Systems, LLC2024-12-04DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024671953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024671953008100246719538100246719530810024671953

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Regulatory Flags#

DUNS number
117126091
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
true
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
00810024671885CPS Locator 3D, Small Delivery CatheterDS2C100-42DS2C100-422026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterDS2C200-422026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterDS2C300-42DS2C300-422026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterDS2C200-45DS2C200-452026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterDS2C300-45DS2C300-452026-07-13
00810024672134CPS Locator 3D, BB1-36DS2CBB1-36DS2CBB1-362026-03-30
00810024672141CPS Locator 3D, BB1-40DS2CBB1-40DS2CBB1-402026-03-30
00810024671991AuST Steerable Sheath0-132H-H3574SAN0-SNSP02026-01-29
00810024672004AuST Steerable Sheath0-132H-H5074SAN0-SNSP02026-01-29
00810024670314AuST Steerable Sheath0-120H-H1774SAN5-SNSP02026-01-12
00810024670536AuST Steerable Sheath0-085H-H1774SAN0-SNSP02026-01-12
00810024670543AuST Steerable Sheath0-085H-H2274SAN0-SNSP02026-01-12
00810024670550AuST Steerable Sheath0-085H-H5074SAN0-SNSP02026-01-12
00810024671724DF4 Helix Locking ToolA002HELX2025-12-03
00810024671342AuST Steerable Sheath0-085H-H1744SAN0-SNSP02025-11-05
00810024671359AuST Steerable Sheath0-085H-H2244SAN0-SNSP02025-11-05
00810024671366AuST Steerable Sheath0-085H-H3544SAN0-SNSP02025-11-05
00810024671373AuST Steerable Sheath0-085H-H5044SAN0-SNSP02025-11-05
00810024671380AuST Steerable Sheath0-132H-H3544SAN0-SNSP02025-11-05
00810024671397AuST Steerable Sheath0-132H-H5044SAN0-SNSP02025-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902189452ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902218145ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219692ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20