FDA.reportPublic FDA data

Vortek

Primary DI
03600040910924
Brand
Vortek
Company
Coloplast A/S
Model
ACA208
Catalog number
ACA208
Device description
Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stiff.
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FADStent, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201436000Vortek Single Loop Ureteral StentColoplast Corp.2021-02-25FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040910887PackageGS124In Commercial Distribution
03600040910924PackageGS11In Commercial Distribution
03600040910962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040910887036000409108873600040910887
03600040910924036000409109243600040910924
03600040910962036000409109623600040910962

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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05708932787888Titan Prime5400155400152026-08-14
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05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14
00762123030196Conveen Security+21346213462022-03-11
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00821925004221URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004238URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004245URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004252URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
00821925004429URO-GUIDEGyrus ACMI, LLCFAD2015-10-24
08714729005254Percuflex™ Combination Stent/Nephrostomy CatheterBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031680Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031697Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729032113Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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08714729048411Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048428Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
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