FDA.reportPublic FDA data

SAT CenterFlow Molding Balloon Catheter

Primary DI
06009880940004
Brand
SAT CenterFlow Molding Balloon Catheter
Company
STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
Model
IN20-00313
Catalog number
IN20-00313
Device description
The SAT CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. Introducer sheath compatible, 18 Fr.
Published
2025-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K243184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243184000SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings2025-06-25DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009880940004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880940004060098809400046009880940004

GMDN Terms#

Term, Definition table
TermDefinition
Aortic endovascular implant post-dilation balloon catheterA flexible tube or shaft with an inflatable balloon(s) at its distal end intended for percutaneous introduction to dilate and stabilize within the aorta a previously deployed aortic endovascular implant (e.g., stent-graft) [not included]; it is not intended for vessel occlusion. It typically includes a guidewire, inflation port, and haemostasis valve. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
539063485
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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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
06934955914836Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914843Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914898Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914904Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914911Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914928Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
00810024671885CPS Locator 3D, Small Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
10801902218732ARROWTELEFLEX INCORPORATEDDQY2026-06-24