FDA.reportPublic FDA data

DLP® Carpentier™

Primary DI
00643169114500
Brand
DLP® Carpentier™
Company
MEDTRONIC, INC.
Model
CB58629
Device description
CANN CB58629 FEM VEN 24/29FR
Published
2016-04-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915268000CATHETER TWO STAGE VENOUS RETURNDlp, Inc.1992-07-27DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169114500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169114500006431691145006431691145000643169114500

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, femoralA sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994836977SHERPA NX BALANCEDSB7AR1052016-06-12
00613994837479SHERPA NX BALANCEDSB7EBU4552016-06-12
00613994837516SHERPA NX BALANCEDSB7EBU4052016-06-12
00613994837585SHERPA NX BALANCEDSB7EBU3552016-06-12
00613994842183SHERPA NX ACTIVESA6JL5052016-05-30
00613994842190SHERPA NX ACTIVESA6EBU4552016-05-30
00613994842206SHERPA NX ACTIVESA6EBU4052016-05-30
00613994842213SHERPA NX ACTIVESA6EBU3552016-05-30
00613994842220SHERPA NX ACTIVESA6AR2052016-05-30
00613994842237SHERPA NX ACTIVESA6AR1052016-05-30
00613994842244SHERPA NX ACTIVESA6AL2052016-05-30
00613994842374SHERPA NX ACTIVESA6AL1052016-05-30
00613994845290Z2Z26JR3552016-06-11
00613994846440SHERPA NX BALANCEDSB6JL5052016-06-12
00613994931405Z2Z26EBU35D2023-01-16
00763000416225LauncherLA5AL1052021-08-01
00763000416232LauncherLA5AL2052021-08-01
00763000416249LauncherLA5AR1052021-08-01
00763000416256LauncherLA5AR2052021-08-01
00763000416263LauncherLA5EBU3552021-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846012962NAMEDTRONIC, INC.DWF2026-08-14
00824846013099NAMEDTRONIC, INC.DWF2026-08-14
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25
08033178019378Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
08033178019385Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
00199150083855NAMEDTRONIC, INC.DWF2026-06-08