Panels › Cardiovascular › Product code MJN · Class 2
Catheter, Intravascular Occluding, Temporary
Regulation 870.4450
0510(k)s in 12 months (90 all time)
0recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in MJN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2021 | W. L. Gore & Associates Inc. Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489 Open, Classified |
MJN | K172567 |
| Oct 29, 2020 | Prytime Medical Devices, Inc. PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for tem Terminated |
MJN | K193440 |
| Mar 31, 2020 | Spectranetics Corporation Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Markin Terminated |
MJN | K153530 |
| Jul 24, 2019 | LeMaitre Vascular, Inc. The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon Terminated |
MJN | K132022 |
| Oct 1, 2018 | LeMaitre Vascular, Inc. LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile
Model # 2014-10 Terminated |
MJN | K152833 |
| Aug 26, 2017 | Spectranetics Corporation Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only.
Product U Terminated |
MJN | K153530 |
| Nov 28, 2016 | Spectranetics Corporation Bridge Occlusion Balloon. Model: 590-001
Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedu Terminated |
MJN | K140775 |
| Oct 6, 2016 | AccessClosure, Inc., A Cardinal Health Company The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path Terminated |
MJN | K143613 |
| Dec 31, 2015 | RenovoRx, Inc. RenovoCath RC 120;
Temporary Intravascular Occluding Catheter
Model number: MMRC120-DB-1111;
Rx only.
Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and del Terminated |
MJN | K141175 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number:
M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsio Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number:
M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 5MM X 30MM, Catalog Number:
M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL-1 Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 5MM X 15MM, Catalog Number:
M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 4MM X 30MM, Catalog Number:
M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL-10 Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 4MM X 20MM, Catalog Number:
M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL-10 Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 4MM X 15MM, Catalog Number:
M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by
Excelsior SL-10/Excelsior 1018 Microcatheter: Stryk Terminated |
MJN | K122576 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand COMPLIANT 4MM X 10MM, Catalog Number:
M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsior SL-10 Terminated |
MJN | K122576 |
| Oct 19, 2011 | Lemaitre Vascular, Inc. LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port
The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carot Terminated |
MJN | K051067 |
| Mar 8, 2011 | AGA Medical Corporation AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442.
The AMPLATZER Sizing Balloon II is intended for use in those patients wit Terminated |
MJN | K053440 |
| Oct 3, 2008 | Edwards Lifesciences, LLC Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter
Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system. Terminated |
MJN | None listed |
| Sep 3, 2008 | AGA Medical Corporation AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. A triple lumen balloon catheter with Terminated |
MJN | K053440 |
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