FDA.reportPublic FDA data

Merit Pursue™

Primary DI
10884450358501
Brand
Merit Pursue™
Company
Merit Medical Systems, Inc.
Model
00884450358504
Catalog number
28HC17110ST/A
Published
2019-05-20
Public version status
New
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
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173548000Merit Pursue MicrocatheterMerit Medical Systems, Inc.2018-03-30DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450358501PackageGS120In Commercial Distribution
00884450358504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445035850110884450358501
00884450358504008844503585048844503585040884450358504

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). 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

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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270377Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270384Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270520Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270223Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
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00763000270247Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270308Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270315Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270322Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270339Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270391Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07