FDA.reportPublic FDA data

Vessel Cannula, 3mm

Primary DI
20634624533039
Brand
Vessel Cannula, 3mm
Company
QUEST MEDICAL INC
Model
VCC-03
Catalog number
VCC-03
Published
2016-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K971928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971928000QUEST VESSEL CATHETERQuest Medical, Inc.1997-11-06DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624533039PrimaryGS10
00634624533035Unit of UseGS10
90634624533039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462453303920634624533039
00634624533035006346245330356346245330350634624533035
9063462453303990634624533039

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding solution kitA collection of sterile devices intended as an alternative to vascular clamping to interrupt local blood flow through transient intraluminal obstruction during surgery, suturing of blood vessels, or interventional vascular procedures. It includes a liquid polymer (e.g., poloxamer) that is injected into a vein/artery, and devices to contain/administer the solution (e.g., pouch, syringe, injection cannula or catheter). The solution typically has reverse thermal characteristics (i.e., liquid at room temperature and gelled at body temperature) enabling the formation of an in vivo plug that occludes the vessel; it eventually dissolves or is purposely dissolved. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041810693
Device count
20
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634624531024MPS 3 Delivery Set w/AA w/305cm Line50031022020-07-27
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05
00634624901032Q2 IV Administration SetASV103Y2020-06-25
00634624911048High-Flow Extension SetHF01352022-12-12
00634624911062Precision Delivery IV Extension SetPD06F2022-10-26
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624921115High-Flow 4-Way Stopcock ExtensionHFSTV022022-12-05
00634624921245High-Flow 4-Way Stopcock ExtensionHFST012022-11-30
00634624921382Precision Delivery IV Extension SetPDB05CV12022-09-15
00634624921399Precision Delivery IV Extension SetPDB05CV22022-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
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