FDA.reportPublic FDA data

EverCross™

Primary DI
00763000185992
Brand
EverCross™
Company
EV3, INC
Model
AB35W03150080
Device description
PTA AB35W03150080 EVERCROSS 035 V09
Published
2019-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110319000EVERCROSS 0.035 OTW PTA DILATATION CATHETEREv3, Inc.2011-04-14LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000185992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000185992007630001859927630001859920763000185992

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length80Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store the EverCross catheter in a cool, dry, and dark place, at room temperature. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169996090TrailBlazer™SC-014-1352017-10-15
00643169996106TrailBlazer™SC-014-1502017-10-15
00643169996113TrailBlazer™SC-018-0902017-10-15
00643169996120TrailBlazer™SC-018-1352017-10-15
00643169996137TrailBlazer™SC-018-1502017-10-15
00643169996144TrailBlazer™SC-035-0652017-10-15
00643169996151TrailBlazer™SC-035-0902017-10-15
00643169996168TrailBlazer™SC-035-1352017-10-15
00643169996175TrailBlazer™SC-035-1502017-10-19
00763000104740TrailBlazer™SC-014-1352019-02-28
00763000104757TrailBlazer™SC-014-1502019-02-28
00763000104764TrailBlazer™SC-018-0902019-02-28
00763000104771TrailBlazer™SC-018-1352019-02-28
00763000104788TrailBlazer™SC-018-1502019-02-28
00763000104795TrailBlazer™SC-035-0652019-02-28
00763000104801TrailBlazer™SC-035-0902019-02-28
00763000104818TrailBlazer™SC-035-1352019-02-28
00763000104825TrailBlazer™SC-035-1502019-02-28
00821684057971TrailBlazer™SC-014-1352016-04-04
00821684057988TrailBlazer™SC-014-1502016-04-04

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00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
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