FDA.reportPublic FDA data

DLP®

Primary DI
00643169454590
Brand
DLP®
Company
MEDTRONIC, INC.
Model
30317
Device description
CANNULA 30317 COR SIL BODY 17FR 10PK 17L
Published
2016-09-09
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
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
K141951000
K230960000
K231206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141951000DLP SILICONE CORONARY ARTERY OSTIAL CANNULAEMedtronic, Inc.2014-08-15DWF
K230960000DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-05-04DWF
K231206000DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-12-07DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20643169454594PackageGS110In Commercial Distribution
00643169454590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316945459420643169454594
00643169454590006431694545906431694545900643169454590

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge17French

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169705753MyCareLink™24950JLQ2016-05-28
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846024767NAMEDTRONIC, INC.DWF2026-10-26
04037691730660NAMaquet Cardiopulmonary AGDWF2015-11-04
04037691730677NAMaquet Cardiopulmonary AGDWF2015-11-04
00803622104091Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104107Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104114Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104121Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104138Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104145Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104152Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104169Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622105692Venous cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104176Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104183Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104190Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104206Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104213Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104220Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104237Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104244Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104251Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104268Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104275Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104282Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104299Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104305Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104312Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104329Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104336Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104343Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17