FDA.report

Merit Maestro®

Primary DI
00884450742945
Brand
Merit Maestro®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
28MC2816545
Published
2024-04-24
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

Related Records

Product Codes

CodeName
KRACatheter, continuous flush

Product Code Classifications

CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions

SubmissionSupplement
K230636000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230636000Maestro MicrocatheterMerit Medical System, Inc.2023-03-30KRA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884450742945PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

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

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10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450826178Fountain®Merit Medical Systems, Inc.KRA2026-03-21
10884450470418Fountain®Merit Medical Systems, Inc.KRA2026-03-19
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-03-13
00860008103819Recana Debulking CatheterIntervene, Inc.KRA2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.KRA2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.KRA2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.KRA2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.KRA2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.KRA2026-03-02
10884450826352Fountain®Merit Medical Systems, Inc.KRA2026-02-21
10884450826222Fountain®Merit Medical Systems, Inc.KRA2026-02-18
10884450826543Fountain®Merit Medical Systems, Inc.KRA2026-02-14
10884450826635Fountain®Merit Medical Systems, Inc.KRA2026-02-14
G544ADM18130Agile AnglerAgile Devices, Inc.KRA2026-01-30
G544ADM18147Agile AnglerAgile Devices, Inc.KRA2026-01-30
10884450826185Fountain®Merit Medical Systems, Inc.KRA2026-01-29
10884450826208Fountain®Merit Medical Systems, Inc.KRA2026-01-16
00884450742921Merit Maestro®Merit Medical Systems, Inc.KRA2026-01-03
10884450826512Fountain®Merit Medical Systems, Inc.KRA2025-11-12
00857136004316TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00857136004323TriNav XP Infusion SystemSUREFIRE MEDICAL, INC.KRA2025-09-29
00884450742914Merit Maestro®Merit Medical Systems, Inc.KRA2025-09-19
10884450826420Fountain®Merit Medical Systems, Inc.KRA2025-08-06
10884450826482Fountain®Merit Medical Systems, Inc.KRA2025-06-03
10884450825997Fountain®Merit Medical Systems, Inc.KRA2025-05-16
10884450825546Fountain®Merit Medical Systems, Inc.KRA2025-05-13
10884450826413Fountain®Merit Medical Systems, Inc.KRA2025-05-13
00842429106228PG PROMICROVENTION INC.KRA2025-04-30
00842429118733VIA MicrocatheterMICROVENTION INC.KRA2025-04-30