FDA.reportPublic FDA data

Wholey™

Primary DI
20763000919614
Brand
Wholey™
Company
EV3, INC
Model
WWSS35260
Device description
GW WWSS35260 WHOLEY WIRE STND STR 260CM
Published
2024-06-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120863000WHOLEY GUIDE WIRE SYSTEMCovidien, LLC2012-04-19DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000919614PackageGS13In Commercial Distribution
00763000919610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300091961420763000919614
00763000919610007630009196107630009196100763000919610

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0.089Centimeter
Guidewire Length260Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150028399Liberant™LMT-TRX2026-05-07
00821684071397Protégé™ GPS™SERB65-09-20-1202015-09-04
00821684071403Protégé™ GPS™SERB65-09-20-802015-09-04
00821684071410Protégé™ GPS™SERB65-09-30-1202015-09-04
00821684071427Protégé™ GPS™SERB65-09-30-802015-09-04
00821684071434Protégé™ GPS™SERB65-09-40-1202015-09-04
00821684071441Protégé™ GPS™SERB65-09-40-802015-09-04
00821684071458Protégé™ GPS™SERB65-09-60-1202015-09-04
00821684071465Protégé™ GPS™SERB65-09-60-802015-09-04
00821684071472Protégé™ GPS™SERB65-09-80-1202015-09-04
00821684071489Protégé™ GPS™SERB65-09-80-802015-09-04
00821684071496Protégé™ GPS™SERB65-10-20-1202015-09-01
00821684071502Protégé™ GPS™SERB65-10-20-802015-09-01
00821684071519Protégé™ GPS™SERB65-10-30-1202015-09-01
00821684071526Protégé™ GPS™SERB65-10-30-802015-09-01
00821684071533Protégé™ GPS™SERB65-10-40-1202015-09-01
00821684071540Protégé™ GPS™SERB65-10-40-802015-09-01
00821684071557Protégé™ GPS™SERB65-10-60-1202015-09-01
00821684071564Protégé™ GPS™SERB65-10-60-802015-09-01
00821684071571Protégé™ GPS™SERB65-10-80-1202015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
00816349014994CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015007CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015014CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015021CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015038CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015045CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015052CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015069CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015076CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25
00816349012587Safari2Lake Region MedicalDQX2026-06-25
00816349012594Safari2Lake Region MedicalDQX2026-06-25
00816349013676WallStentLake Region MedicalDQX2026-06-25
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30