FDA.reportPublic FDA data

CLEARVIEW®

Primary DI
20885074257406
Brand
CLEARVIEW®
Company
MEDTRONIC, INC.
Model
31125
Device description
SHUNT 31125 ARTERIOTOMY 1.25MM 5PK 15LA
Published
2020-07-27
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
K120612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120612000MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTMedtronic, Inc.2012-05-25DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885074257406PrimaryGS10
00885074257402Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088507425740620885074257406
00885074257402008850742574028850742574020885074257402

GMDN Terms#

Term, Definition table
TermDefinition
Surgical intravascular shuntA sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.25Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
08033178019620Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019637Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019644Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019651Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019668Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019675Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
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
08033178019057Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019064Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019071Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019088Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019095Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019101Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019118Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11