FDA.reportPublic FDA data

DLP® Carpentier™

Primary DI
00643169114517
Brand
DLP® Carpentier™
Company
MEDTRONIC, INC.
Model
CB58633
Device description
CANN CB58633 FEM VEN 30/33FR
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
00643169114517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169114517006431691145176431691145170643169114517

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
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11