FDA.reportPublic FDA data

Impress®

Primary DI
10884450043339
Brand
Impress®
Company
Merit Medical Systems, Inc.
Model
00884450043332
Catalog number
510038SIM2-H
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093004000IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATINGMerit Medical Systems, Inc.2010-02-12DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450043339PackageGS15In Commercial Distribution
00884450043332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445004333910884450043339
00884450043332008844500433328844500433320884450043332

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
00816777025920Sofia 5F-115cm STRMicrovention, Inc.DQO2018-08-07
00857688007278Respiguide Delivery SystemRESPICARDIA, INC.DQO2018-04-30
00884450089194EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00884450089200EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00866749000202Morph Universal Deflectable Guide CatheterBIOCARDIA, INC.DQO2016-10-10
08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200574Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24