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Data / Medical devices / Catheter, Percutaneous / United States

FDA-registered makers of Catheter, Percutaneous in the United States: 127 establishments

127 establishments in the United States are registered with the FDA to make Catheter, Percutaneous (product code DQY). 93 have a 510(k) clearance or PMA approval on file and 27 have a recall event. FDA data exported November 3, 2026.

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Device
Catheter, Percutaneous
Product code
DQY
Country
United States

Makers of Catheter, Percutaneous in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
St. Jude MedicalRoseville, MN, United StatesManufacturer20July 2, 2026000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer19August 18, 2022000api.fda.gov
Abbott MedicalPlymouth, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export17July 2, 2026000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesManufacturer, Specification developer17July 2, 2026000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Specification developer17February 1, 2024020api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Repackager or relabeler, Specification developer17January 10, 2023030api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer15December 15, 2019080api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Manufacturer for export, Specification developer14June 2, 2023010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer14February 1, 2024000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer14December 12, 2019071api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Manufacturer for export, Specification developer13February 1, 20240151api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer, Manufacturer for export12June 30, 2022000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer12June 28, 2024050api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer, Manufacturer for export, Specification developer12August 22, 2023051api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer11June 23, 20170160api.fda.gov
Reflow Medical, IncSan Clemente, CA, United StatesManufacturer11August 22, 2025011api.fda.gov
Reflow MedicalLake Forest, CA, United StatesContract manufacturer, Manufacturer11February 8, 2024000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Specification developer11August 18, 2022052api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export10April 29, 2025000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer10June 11, 2020000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer, Specification developer10September 22, 2016030api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer9December 19, 2025050api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer9May 28, 2024000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer9June 11, 2020030api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer9June 11, 2020000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer9June 11, 2020000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler9June 23, 2017000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer8May 4, 2022070api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer7July 29, 2026000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer6November 8, 2019000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer6August 31, 2012000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler, Specification developer5January 15, 2025020api.fda.gov
Teleflex LLCBrooklyn Park, MN, United StatesManufacturer5April 30, 2021000api.fda.gov
Alembic LLCMountain View, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3May 1, 2025000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer3February 27, 2015020api.fda.gov
Stryker NeurovascularSalt Lake City, UT, United StatesManufacturer3January 27, 2016000api.fda.gov
W. L. Gore & Associates, Inc.Phoenix, AZ, United StatesManufacturer3June 2, 2025000api.fda.gov
Abbott VascularMenlo Park, CA, United StatesManufacturer, Manufacturer for export2December 31, 2024000api.fda.gov
Biocardia, Inc.Sunnyvale, CA, United StatesManufacturer2January 7, 2020000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2August 8, 2023010api.fda.gov
Cardiovascular Systems IncorporatedSaint Paul, MN, United StatesComplaint file establishment, Specification developer2August 26, 2021000api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer2December 14, 2018000api.fda.gov
Okami Medical Inc.Aliso Viejo, CA, United StatesManufacturer2December 20, 2024000api.fda.gov
Q'apel Medical, Inc.Fremont, CA, United StatesManufacturer2October 31, 2019000api.fda.gov
Qxmedical, LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer, Manufacturer for export2November 2, 2016000api.fda.gov
Route 92 Medical, Head QuartersSan Mateo, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2January 13, 2020011api.fda.gov
Route 92 Medical, West JordanW Jordan, UT, United StatesManufacturer, Repackager or relabeler2January 13, 2020000api.fda.gov
Seigla Medical, Inc.Buffalo, MN, United StatesSpecification developer2April 4, 2025000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2October 14, 2022000api.fda.gov
W. L. Gore & Associates, IncFlagstaff, AZ, United StatesManufacturer2October 5, 2018000api.fda.gov
Wallaby MedicalLaguna Hills, CA, United StatesSpecification developer2October 13, 2023000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer2October 21, 2021000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer1August 15, 2012000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer1February 15, 1991010api.fda.gov
Asahi Intecc Usa, Inc.Tustin, CA, United StatesSpecification developer1November 29, 2019000api.fda.gov
Atricure, Inc.Mason, OH, United StatesComplaint file establishment, Manufacturer1February 8, 2008000api.fda.gov
Axiom Medical, Inc.Torrance, CA, United StatesManufacturer1August 1, 1984000api.fda.gov
Abbott MedicalWestfield, IN, United StatesManufacturer, Manufacturer for export1December 31, 2024000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer1February 15, 1991000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer1August 25, 1986011api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer1February 8, 2008000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1March 11, 1981000api.fda.gov
Balosmark, IncKalamazoo, MI, United StatesSpecification developer1June 5, 2026000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer1March 21, 2019011api.fda.gov
Basis MedicalMiami, FL, United StatesSpecification developer1February 28, 2025000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1October 2, 2003000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1March 20, 2008000api.fda.gov
Brevet Inc.Huntington Beach, CA, United StatesManufacturer1November 14, 1989000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer1August 12, 1987010api.fda.gov
Boston Scientific CorporationDorado, PR, United StatesManufacturer1April 3, 2014000api.fda.gov
Cardiovascular Systems IncorporatedHouston, TX, United StatesManufacturer1December 29, 2018000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1October 2, 2003000api.fda.gov
Eosolutions, Corp.Miramar, FL, United StatesSpecification developer1July 29, 2022000api.fda.gov
Elumn8 Medical, IncCampbell, CA, United StatesManufacturer1December 19, 2024000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler1July 7, 2021000api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer1July 7, 2021000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer1July 12, 2016000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer1September 26, 2018000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1August 8, 2018000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer, Specification developer1June 26, 1985000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 10, 1984000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer1December 21, 1988010api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer1July 17, 2003000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1December 21, 1988000api.fda.gov
Medtronic VascularSanta Rosa, CA, United StatesSpecification developer1April 13, 2005020api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesSpecification developer1October 17, 2013000api.fda.gov
Scientia VascularWest Valley City, UT, United StatesManufacturer1April 28, 2021010api.fda.gov
Shockwave Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer1May 2, 2025000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesSpecification developer1January 12, 2018000api.fda.gov
Surefire Medical, Inc.Westminster, CO, United StatesComplaint file establishment, Manufacturer1December 27, 2023000api.fda.gov
Terumo Medical Corp.Elkton, MD, United StatesManufacturer1July 27, 2023000api.fda.gov
Vantis Vascular, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer1September 30, 2024000api.fda.gov
W. L. Gore & Associates, Inc.Elkton, MD, United StatesManufacturer1October 5, 2018000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cathx Medical IncSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Centerline BiomedicalCleveland, OH, United StatesManufacturer0000api.fda.gov
CPE1, LLC DBA Greatbatch MedicalSouthwest Ranches, FL, United StatesContract manufacturer0000api.fda.gov
Crossroads NeurovascularLake Forest, CA, United StatesManufacturer for export0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Infinity Neuro, LLCLake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Lake Region MedicalTrenton, GA, United StatesContract manufacturer0000api.fda.gov
M4D LLCLake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Maduro Medical, Inc.Los Gatos, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Meraqi Medical, Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
Midwest Sterilization Corp.Laredo, TX, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Midwest Sterilization Corp.Jackson, MO, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0010api.fda.gov
Norman Noble, Inc.Highland Heights, OH, United StatesContract manufacturer0000api.fda.gov
NeuroVasc Technologies, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Piraeus Medical, Inc.Maple Grove, MN, United StatesManufacturer0000api.fda.gov
Provisio Medical Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Prytime Medical Devices, Inc.Lakewood, CO, United StatesSpecification developer0000api.fda.gov
Prytime Medical Devices, Inc.Boerne, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Resolution MedicalMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Sonorous NV, Inc.Lake Forest, CA, United StatesSpecification developer0000api.fda.gov
Sterigenics U.S., LLCQueensbury, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Toro Neurovascular, Inc.Irvine, CA, United StatesSpecification developer0000api.fda.gov
VesalioSan Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Verge Medical Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 3, 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.