FDA.reportPublic FDA data

CPS Locator 3D Plus Delivery Catheter

Primary DI
00810024670994
Brand
CPS Locator 3D Plus Delivery Catheter
Company
CENTERPOINT SYSTEMS LLC
Model
DS4D300-42
Device description
The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
Published
2025-07-07
Public version status
Update
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
K250828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250828000CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC2025-06-27DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024670994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024670994008100246709948100246709940810024670994

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. 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
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
00810024673131FieldFlex SheathFXS-MD-0015992026-10-23
00810024673148FieldFlex SheathFXS-MD-0020002026-10-23
00810024672011CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-42DS5D200-422026-08-04
00810024672028CPS Locator 3D Plus, Large Delivery CatheterDS5D300-42DS5D300-422026-08-04
00810024672035CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-42DS5D400-422026-08-04
00810024672042CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-45DS5D200-452026-08-04
00810024672059CPS Locator 3D Plus, Large Delivery CatheterDS5D300-45DS5D300-452026-08-04
00810024672066CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-45DS5D400-452026-08-04
00810024672196CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-48DS5D200-482026-08-04
00810024672202CPS Locator 3D Plus, Large Delivery CatheterDS5D300-48DS5D300-482026-08-04
00810024672219CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-48DS5D400-482026-08-04
00810024672554AuST Steerable SheathADS-MD-0029572026-08-06
00810024672561AuST Steerable SheathADS-MD-0029582026-08-06
00810024672578AuST Steerable SheathADS-MD-0029592026-08-06
00810024672585AuST Steerable SheathADS-MD-0029602026-08-06
00810024672592AuST Steerable SheathADS-MD-0029612026-08-06
00810024672608AuST Steerable SheathADS-MD-0029622026-08-06
00810024672615AuST Steerable SheathADS-MD-0029632026-08-06
00810024672622AuST Steerable SheathADS-MD-0029642026-08-06
00810024672639AuST Steerable SheathADS-MD-0029652026-08-06

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Primary DI, Brand, Company table
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00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
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