Panels › Cardiovascular › Product code LIT · Class 2
Catheter, Angioplasty, Peripheral, Transluminal
Regulation 870.1250
5510(k)s in 12 months (405 all time)
2recalls in 12 months (32 all time)
28recalls that name a 510(k)
Top companies in LIT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2017 | K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature Angioslide, Ltd., IL | LIT |
| Dec 13, 2017 | K173621 | Advocate PTA Catheter Merit Medical Systems, Inc., IE | LIT |
| Sep 8, 2017 | K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter Creagh Medical, IE | LIT |
| Aug 31, 2017 | K172033 | Pirouette High Pressure (HP) Arravasc, Ltd., IE | LIT |
| Jul 19, 2017 | K171290 | Vela RX PTA Balloon Dilatation Catheter Curatia Medical | LIT |
| Mar 30, 2017 | K170635 | Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd., IL | LIT |
| Feb 13, 2017 | K170193 | Advance 14LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated | LIT |
| Jan 17, 2017 | K163231 | Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd., IL | LIT |
| Jan 11, 2017 | K163479 | R2P Metacross RX KANEKA Corporation, JP | LIT |
| Dec 13, 2016 | K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LIT |
| Nov 22, 2016 | K162316 | Pirouette 014 Arravasc, Ltd., IE | LIT |
| Nov 4, 2016 | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounte Boston Scientific Corporation | LIT |
| Jul 30, 2016 | K161427 | Pirouette 035 Arravasc Limited, IE | LIT |
| Jul 29, 2016 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LIT |
| Apr 29, 2016 | K160013 | Crosperio OTW KANEKA Corporation, JP | LIT |
| Apr 29, 2016 | K160004 | Crosstella OTW KANEKA Corporation, JP | LIT |
| Apr 25, 2016 | K152934 | MMS PTA Balloon Catheter Micro Medical Solutions, Inc. | LIT |
| Jan 22, 2016 | K152887 | Crosperio RX PTA Balloon Dilatation Catheter KANEKA Corporation, JP | LIT |
| Jan 22, 2016 | K152873 | Crosstella RX Balloon Dilatation Catheter KANEKA Corporation, JP | LIT |
| Jan 14, 2016 | K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter Nipro Medical Corporation | LIT |
| Oct 26, 2015 | K152665 | PolarCath Peripheral Dilatation System Nucyro Vascular, LLC | LIT |
| Oct 8, 2015 | K152240 | Passeo-14 Peripheral Dilatation Catheter Biotronik, Inc. | LIT |
| Oct 8, 2015 | K151744 | Passeo-18 Peripheral Dilation Catheter Biotronik, Inc. | LIT |
| Sep 24, 2015 | K152080 | Metacross OTW PTA Balloon Dilatation Catheter KANEKA Corporation, JP | LIT |
| Sep 21, 2015 | K151678 | Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd., IL | LIT |
| Sep 3, 2015 | K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter Natec Medical, MU | LIT |
| Aug 20, 2015 | K151153 | Pirouette 018 Arravasc Limited, IE | LIT |
| Aug 13, 2015 | K150452 | ComboCath OTW PTA Dilatation Catheter Summa Therapeutics, LLC | LIT |
| Jul 24, 2015 | K143193 | Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters Boston Scientific | LIT |
| Jul 6, 2015 | K151317 | Armada 18 PTA Catheter Abbott Vascular | LIT |
| Jun 24, 2015 | K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) Hotspur Technologies, Inc., | LIT |
| Jun 15, 2015 | K150303 | XXL Vascular Balloon Dilatation Catheter Boston Scientific Corp | LIT |
| Jun 4, 2015 | K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter Natec Medical , Ltd., MU | LIT |
| May 28, 2015 | K142954 | PTA 14 Balloon Dilatation Catheter OTW Texasmedical Technologies, Inc. | LIT |
| May 19, 2015 | K143561 | ELM PTA Balloon Dilatation Catheter O'Connell Regulatory Consultants, Inc. | LIT |
| May 8, 2015 | K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm Ostial Corporation | LIT |
| Mar 30, 2015 | K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter Natec Medical , Ltd., MU | LIT |
| Feb 26, 2015 | K143652 | Vector PTA Balloon Dilatation Catheter Vector Corporation, LLC | LIT |
| Feb 3, 2015 | K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter Natec Medical , Ltd., MU | LIT |
| Dec 5, 2014 | K142379 | Passeo-35 PTA Catheter Biotronik, Inc. | LIT |
| Oct 28, 2014 | K142654 | Fortrex 0.035 OTW PTA Balloon Catheter Covidien, LLC | LIT |
| Sep 25, 2014 | K141150 | PTA BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Sep 24, 2014 | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. | LIT |
| Sep 17, 2014 | K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) Hotspur Technologies, Inc., | LIT |
| Aug 21, 2014 | K141521 | MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER Boston Scientific Corporation | LIT |
| Jul 18, 2014 | K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| Jul 16, 2014 | K141112 | STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER Boston Scientific | LIT |
| Jul 2, 2014 | K140351 | ARROW GPSCATH BALLOON DILATATION CATHETER Hotspur Technologies,Inc Subsidiary of Teleflex ME | LIT |
| Jul 2, 2014 | K133861 | FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM Ostial Corporation | LIT |
| Jun 27, 2014 | K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER Cordis Corporation | LIT |
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