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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | SUMMA THERAPEUTICS, LLC Brand Name: Finesse BTK Multicath
Product Name: Injectable Angioplasty Balloon Catheter
Model/Catalog Number: FS252251502
Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wir Open, Classified |
LIT | K230263 K241740 |
| Jan 9, 2026 | Boston Scientific Corporation Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,
1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;
2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;
Cat Open, Classified |
LIT | K111295 |
| Jan 15, 2025 | ev3 Inc Medtronic NanoCross Elite PTA catheter,
REF numbers amd sizes:
1) AB14W050020090, Size: 5MM X 20MM X 90CM;
2) AB14W050020150, Size: 5MM X 20MM X 150CM;
3) AB14W050040090, Size: 5MM X 40MM X Open, Classified |
LIT | K141118 |
| Oct 29, 2024 | Covidien LP Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US Open, Classified |
LIT | K163231 |
| Feb 3, 2022 | Covidien Llc Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US Open, Classified |
LIT | K163231 |
| Jul 19, 2021 | Cordis Corporation Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X Terminated |
LIT | K133843 |
| Jul 14, 2021 | Ostial Corporation FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA Terminated |
LIT | K122379 |
| Aug 26, 2020 | ev3 Inc. Pacific Xtreme (PTCA Balloon Dilation Catheter) Terminated |
LIT | K103464 |
| Feb 28, 2020 | Cordis Corporation Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S Terminated |
LIT | K032737 |
| Oct 11, 2019 | Nucryo Vascular Inc. The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is avai Terminated |
LIT | K152665 |
| Oct 4, 2019 | Cordis Corporation Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. Terminated |
LIT | K991811 |
| Aug 14, 2019 | Bard Peripheral Vascular Inc Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure Terminated |
LIT | K120660 |
| Dec 14, 2018 | BrosMed Medical Co.,Ltd. Hermes NC PTA Balloon Dilatation Catheter
The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the Terminated |
LIT | K160941 |
| Sep 5, 2018 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obs Terminated |
LIT | K121442 |
| Dec 22, 2016 | Medtronic Inc ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO.
The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapoplit Terminated |
LIT | K093286 |
| Apr 22, 2016 | ev3, Inc. ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. Terminated |
LIT | K093286 |
| Feb 11, 2016 | Us Endovascular USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO. Terminated |
LIT | K152230 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number CF14-150-25040-OTW.
EXP (repackager), TriReme Medical (OEM)
Cathet Terminated |
LIT | None listed |
| Jan 16, 2015 | Cordis Corporation Cordis POWERFLEX PRO PTA Dilatation Catheter
Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of Terminated |
LIT | K121442 |
| Feb 11, 2014 | Boston Scientific Corporation Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151. Terminated |
LIT | K111295 |
| Feb 11, 2014 | Boston Scientific Corporation Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. Terminated |
LIT | K111295 |
| Nov 15, 2013 | Medtronic Vascular THUNDER Steerable Guidewire; Model: LVTNDR190S
Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the corona Terminated |
LIT | K970466 |
| Nov 15, 2013 | Medtronic Vascular THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S
Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or Terminated |
LIT | K970466 |
| Sep 3, 2013 | Boston Scientific Corporation Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation:
1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogu Terminated |
LIT | None listed |
| Sep 3, 2013 | Boston Scientific Corporation Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation:
The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstruc Terminated |
LIT | None listed |
| Sep 25, 2012 | Abbott Vascular Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature. Terminated |
LIT | K111899 |
| Mar 25, 2010 | Boston Scientific Corporation Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland
Recom Terminated |
LIT | K071309 |
| Mar 22, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA.
Indicated to dilate stenosis in the peripheral vasculature Terminated |
LIT | K072798 |
| Dec 15, 2009 | Numed Inc IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only
--- Common/Usual Name: PTA and Esophageal Catheter
--- Manufactured for: B. Braun Interv Terminated |
LIT | K931009 K983373 |
| Feb 1, 2006 | Boston Scientific Corporation The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Terminated |
LIT | K052038 |
| Sep 21, 2005 | Cordis Corporation Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, Th Terminated |
LIT | None listed |
| May 15, 2003 | Boston Scientific Corporation MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr Terminated |
LIT | K934697 |
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