FDA.reportPublic FDA data

OptEase Retrieval Catheter

Primary DI
20705032009376
Brand
OptEase Retrieval Catheter
Company
CORDIS CORPORATION
Model
466C220F
Catalog number
466C220F
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTKFILTER, INTRAVASCULAR, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTKFilter, Intravascular, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140286000OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETERCordis, A Johnson & Johnson Co.2014-03-07DTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032009376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200937620705032009376

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use open or damaged packages
Special Storage Condition, Specify00Store in a cool, dark, dry place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886333217519Option Elite Retrievable Vena Cava FilterARGON MEDICAL DEVICES, INC.DTK2019-07-26
03760017680004ALN Optional Vena Cava Filter - Femoral ApproachA.L.N.DTK2018-10-26
03760017680011ALN Optional Vena Cava Filter - Jugular ApproachA.L.N.DTK2018-10-26
03760017680028ALN Optional Vena Cava Filter - Brachial ApproachA.L.N.DTK2018-10-26
03760017680042ALN Optional Vena Cava Filter - Femoral Approach with HookA.L.N.DTK2018-10-26
03760017680059ALN Optional Vena Cava Filter - Jugular Approach with HookA.L.N.DTK2018-10-26
03760017680066ALN Optional Vena Cava Filter - Brachial Approach with HookA.L.N.DTK2018-10-26
03760017680103ALN Straight RSA.L.N.DTK2018-10-26
03760017680110ALN Pre-Curved RSA.L.N.DTK2018-10-26
03760017680127ALN 2in1A.L.N.DTK2018-10-26
05391529380069Sentry IVC FilterNOVATE MEDICAL LIMITEDDTK2018-09-27
05391529380076Sentry IVC FilterNOVATE MEDICAL LIMITEDDTK2018-09-27
20705032009369OPTEASECORDIS CORPORATIONDTK2017-09-18
04046964332333VENA TECHB. BRAUN MEDICAL INC.DTK2017-01-18
00886333222346Option Elite Retrievable Vena Cava FilterARGON MEDICAL DEVICES, INC.DTK2016-09-23
00886333217151Option Elite Retrievable Vena Cava Filter SystemARGON MEDICAL DEVICES, INC.DTK2016-09-21
04027478130318VENA TECH™B BRAUN INTERVENTIONAL SYSTEMS, INCDTK2016-08-09
04027478130752VENA TECHB BRAUN INTERVENTIONAL SYSTEMS, INCDTK2016-03-17
08714729050650Entry KitBOSTON SCIENTIFIC CORPORATIONDTK2016-01-29
10827002355801Cook CelectWilliam Cook Europe ApSDTK2015-12-07
00857141005001OptionELITE Vena Cava FilterRex Medical LLPDTK2015-12-07
00857141005018OptionELITE Vena Cava Filter, 100cmRex Medical LLPDTK2015-12-07
10827002037660Gunther TulipWilliam Cook Europe ApSDTK2015-10-24
10827002037677Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002213606Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002330167Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002330174Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002355900Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002529097Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002529141Cook CelectWilliam Cook Europe ApSDTK2015-10-24