FDA.reportPublic FDA data

MicroCross 14 ES Catheter, 135cm, CE

Primary DI
00858480007169
Brand
MicroCross 14 ES Catheter, 135cm, CE
Company
ROXWOOD MEDICAL, INC.
Model
RCX-3014
Published
2018-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K143744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143744000MicroCross CatheterRoxwood Medical, Inc.2015-04-14DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858480007169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858480007169008584800071698584800071690858480007169

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055819211
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B094CC01000CenterCross CatheterCC-01002016-04-27
B094CCX01000CenterCross Catheter, CECCX-01002017-08-09
B094LV01000CenterCross Ultra LV CatheterLV-01002017-04-19
B094MC01000MultiCross CatheterMC-01002016-04-27
B094MCX01000MultiCross Catheter, CEMCX-01002017-08-09
B094UC01000CenterCross Ultra CatheterUC-01002017-04-12
B094UCX01000CenterCross Ultra Catheter, CEUCX-01002017-08-09
00858480007008CenterCross CatheterCC-01002017-08-24
00858480007046MultiCross CatheterMC-01002017-08-24
00858480007053CenterCross Ultra CatheterUC-01002017-08-24
00858480007060CenterCross Ultra LV CatheterLV-01002017-08-30
00858480007077CenterCross Catheter,CECCX-01002018-04-19
00858480007084MultiCross Catheter, CEMCX-01002018-04-19
00858480007091CenterCross Ultra Catheter, CEUCX-01002018-04-19
00858480007015Micro14 MicroCross CatheterRC-00142017-08-24
00858480007022Micro18 MicroCross CatheterRC-00182017-08-24
00858480007039Micro14es MicroCross CatheterRC-10142017-08-24
00858480007107Micro14 MicroCross Catheter,CERCX-00142018-04-19
00858480007114Micro14es MicroCross Catheter, CERCX-10142018-04-19
00858480007121Micro18 MicroCross Catheter, CERCX-00182018-04-19

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Primary DI, Brand, Company table
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07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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