FDA.reportPublic FDA data

Micro ACE™

Primary DI
10884450785123
Brand
Micro ACE™
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
ACE521PTE
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232609000Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc.2023-09-27DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450785123PackageGS110In Commercial Distribution
00884450785126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445078512310884450785123
00884450785126008844507851268844507851260884450785126

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
00884450029695Merit Medical®Initial ReleaseK08-02207A2026-07-24
00884450383865Merit Medical®Initial ReleaseK10-01245L2026-07-25
00884450419922SureCrossDSC181352026-07-24
00884450428320Merit Medical®Initial ReleaseK09-10593C2026-07-24
00884450470831Merit Medical®Initial ReleaseK09-12157A2026-07-24
00884450484203Merit Medical®Initial ReleaseK09-144012026-07-24
00884450485569Merit Medical®Initial ReleaseK12T-127302026-07-24
00884450486214Merit Medical®Initial ReleaseK12T-12593A2026-07-24
00884450486955Merit Medical®Initial ReleaseK02-016512026-07-25
00884450545010Aspira®Initial Release49925242026-07-25
00884450545034Aspira®Initial Release4992524B2026-07-25
00884450793817BioFlo DuraMax®AH9651030380112026-07-25
00884450846148Merit Medical®Initial ReleaseK09-14237A2026-07-25
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDRE2023-09-01