FDA.reportPublic FDA data

Mistique®

Primary DI
10884450012151
Brand
Mistique®
Company
Merit Medical Systems, Inc.
Model
00884450012154
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974067000FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREMerit Medical Systems, Inc.1998-02-27QEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450012151PackageGS15In Commercial Distribution
00884450012154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445001215110884450012151
00884450012154008844500121548844500121540884450012154

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal oesophageal stent, non-sterileA non-sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g. anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12
10884450451790Prelude SNAP™DPLS-1008.52026-09-12
10884450451806Prelude SNAP™DPLS-10082026-09-12
10884450451813Prelude SNAP™DPLS-1009.52026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22