FDA.reportPublic FDA data

SSPC2 Delivery Catheter

Primary DI
00810024671823
Brand
SSPC2 Delivery Catheter
Company
CENTERPOINT SYSTEMS LLC
Model
9182
Device description
Catheter and Dilator
Published
2019-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190475000Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4Centerpoint Systems2019-06-28DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024671823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024671823008100246718238100246718230810024671823

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead delivery catheterA sterile, non-steerable, thin flexible tube intended to be introduced percutaneously into the cardiac anatomy (e.g., coronary sinus) to provide a conduit for the delivery of a cardiac pacing and/or defibrillation lead (not included). It may include additional synergistic catheters and is intended to be introduced through a separate catheter introducer sheath, which may be included along with additional devices dedicated to catheter introduction/function. It does not contain electrodes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length40Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-848-0828info@centerpoint-systems.com

Regulatory Flags#

DUNS number
117126091
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810024672646AuST Steerable SheathADS-MD-0029662026-08-06
00810024672653AuST Steerable SheathADS-MD-0029672026-08-06

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