FDA.reportPublic FDA data

DLP®

Primary DI
20613994540465
Brand
DLP®
Company
MEDTRONIC, INC.
Model
12002
Device description
SUCTION 12002 LV VENT 20FR SIL 20PK 17L
Published
2016-05-21
Public version status
Update
Distribution status
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
DRACATHETER, STEERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K834352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834352000ADULT VENT CATHETERDlp, Inc.1984-01-27DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994540465PrimaryGS10
00613994540461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399454046520613994540465
00613994540461006139945404616139945404610613994540461

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge20French

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
20
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671991AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024672004AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024670314AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670536AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670543AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670550AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024671342AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671359AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671366AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671373AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671380AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671397AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671403AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671410AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671427AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671434AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671441AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671571AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671588AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671595AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671601AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671618AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671625AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671632AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671649AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671687AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671694AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671700AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671731AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671748AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05