FDA.reportPublic FDA data

Simon Nitinol Filter™

Primary DI
00801741109195
Brand
Simon Nitinol Filter™
Company
Bard Peripheral Vascular, Inc.
Model
3220J
Catalog number
3220J
Device description
Simon Nitinol Filter™ , Vena Cava Filter, Jugular Introducer Set
Published
2015-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K970099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970099000SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMNitinol Medical Technologies, Inc.1997-04-16DTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741109195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741109195008017411091958017411091950801741109195

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter, temporary/permanentA vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

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