FDA.reportPublic FDA data

SpiderFX

Primary DI
00821684040355
Brand
SpiderFX
Company
Covidien LP
Model
SPD2-US-050-320
Catalog number
SPD2-US-050-320
Device description
Embolic Protection Device
Published
2015-10-16
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
NFATemporary Coronary Saphenous Vein Bypass Graft for Embolic Protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063785000SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2007-01-19NFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684040355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684040355008216840403558216840403550821684040355

GMDN Terms#

Term, Definition table
TermDefinition
Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length320Centimeter
Outer Diameter0.014Inch
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Avoid direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
968903703
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729470854FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729470861FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729479109EZ Bent TipBOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808800FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808817FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
10721902644020GuardWire®MEDTRONIC, INC.NFA2016-09-01
10721902644037GuardWire®MEDTRONIC, INC.NFA2016-05-15
10721902644174GuardWire®MEDTRONIC, INC.NFA2016-05-15
10721902644167GuardWire®MEDTRONIC, INC.NFA2016-05-15
00821684040331SpiderFXCovidien LPNFA2015-10-16
00821684040348SpiderFXCovidien LPNFA2015-10-16
00821684040362SpiderFXCovidien LPNFA2015-10-16
00821684040379SpiderFXCovidien LPNFA2015-10-16
00821684040485SpiderFXCovidien LPNFA2015-10-16
00821684040492SpiderFXCovidien LPNFA2015-10-16
00821684040508SpiderFXCovidien LPNFA2015-10-16
00821684040515SpiderFXCovidien LPNFA2015-10-16
00821684040522SpiderFXCovidien LPNFA2015-10-16