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Data / Medical devices / Catheter, Intravascular Occluding, Temporary / United States

FDA-registered makers of Catheter, Intravascular Occluding, Temporary in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make Catheter, Intravascular Occluding, Temporary (product code MJN). 25 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Intravascular Occluding, Temporary
Product code
MJN
Country
United States

Makers of Catheter, Intravascular Occluding, Temporary in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer8July 13, 2010000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer8July 13, 2010000api.fda.gov
Lemaitre Vascular, Inc.Burlington, MA, United StatesManufacturer4November 16, 2018030api.fda.gov
LeMaitre Vascular Inc.Billerica, MA, United StatesManufacturer4November 16, 2018000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesRepackager or relabeler, Specification developer3November 23, 2015000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesContract manufacturer, Manufacturer3June 20, 2016000api.fda.gov
Prytime Medical Devices, Inc.Lakewood, CO, United StatesSpecification developer3September 5, 2025000api.fda.gov
Prytime Medical Devices, Inc.Boerne, TX, United StatesComplaint file establishment, Specification developer3September 5, 2025010api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer3June 24, 2025031api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2July 22, 2014000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer2November 23, 2015000api.fda.gov
Embolx Inc.Sunnyvale, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 8, 2018000api.fda.gov
Lucas Medical, Inc.Orange, CA, United StatesManufacturer2July 30, 1999000api.fda.gov
Renovorx, Inc.Mountain View, CA, United StatesSpecification developer2August 23, 2021010api.fda.gov
Abbott MedicalPlymouth, MN, United StatesManufacturer, Repackager or relabeler1December 30, 2005000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesSpecification developer1December 30, 2005000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesManufacturer1April 30, 2019000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer1June 19, 2009000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesRepackager or relabeler, Specification developer1August 10, 2012000api.fda.gov
Philips Image Guided Therapy CorporationPlymouth, MN, United StatesManufacturer1June 24, 2025000api.fda.gov
Qxmedical, LLCSaint Paul, MN, United StatesManufacturer1April 24, 2019000api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer1December 30, 2005000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesSpecification developer1January 11, 2013010api.fda.gov
W. L. Gore & Associates, Inc.Phoenix, AZ, United StatesComplaint file establishment, Specification developer1January 31, 2018010api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer1September 19, 2022000api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Cathx Medical IncSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Medical Murray, Inc.Lake Zurich, IL, United StatesContract manufacturer0000api.fda.gov
Midwest Interventional SystemsMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
TacPro, LLC dba Creganna MedicalPlymouth, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.