Atlas FDA

Option (TM) ELITE Vena Cava Filter 100cm System

FDA 510(k) clearance K143405 · decided 2015-04-16

Clearance details

K-number
K143405
Device name
Option (TM) ELITE Vena Cava Filter 100cm System
Applicant
Rex Medical, L.P.
Decision
Substantially Equivalent
Date received
2014-11-28
Decision date
2015-04-16
Days to decision
139 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Conshohocken, PA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Rex Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Option ELITE Vena Cava Filter System (352506070E 352506100E) (K242612)Argon Medical Devices, Inc.2024-09-10
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (K240578)B.Braun Medical, Inc.2024-07-31
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) (K241507)Aln S.A.R.L.2024-06-26
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (K240257)Bd2024-02-29
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter (K233680)William Cook Europe Aps2024-01-18
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211874)William Cook Europe Aps2021-07-28
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211875)William Cook Europe Aps2021-07-28
Sentry IVC Filter (K181202)Novate Medical , Ltd.2018-06-06
Sentry IVC Filter (K173236)Novate Medical , Ltd.2018-02-22
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172557)William Cook Europe Aps2017-11-20
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172584)William Cook Europe Aps2017-11-20
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook (K163699)Aln Implants Chirurgicaux2017-09-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Closer Vascular Sealing System (VSS) (P150022/S007)Rex Medical, L.P.2018-10-01
Closer Vascular Sealing System (VSS) (P150022/S005)Rex Medical, L.P.2018-07-10
Closer Vascular Sealing System (P150022/S004)Rex Medical, L.P.2018-02-07
Closer Vascular Sealing System (VSS) (P150022/S003)Rex Medical, L.P.2018-01-31
CLOSER VASCULAR SEALING SYSTEM (P150022/S002)Rex Medical, L.P.2016-11-10
CLOSER VASCULAR SEALING SYSTEM (P150022/S001)Rex Medical, L.P.2016-06-10
CLOSER VASCULAR SEALING SYSTEM (P150022)Rex Medical, L.P.2016-02-12