FDA.reportPublic FDA data

Micro18 MicroCross Catheter, CE

Primary DI
00858480007121
Brand
Micro18 MicroCross Catheter, CE
Company
ROXWOOD MEDICAL, INC.
Model
RCX-0018
Published
2018-04-19
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
K151082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151082000MicroCross CatheterRoxwood Medical, Inc.2015-06-07DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858480007121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858480007121008584800071218584800071210858480007121

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
00858480007138MicroCross 14 Catheter, 135cmRC-20142018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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