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Data / Medical devices / Wire, Guide, Catheter, Exempt

Wire, Guide, Catheter, Exempt (PTL): 19 FDA-registered makers in 6 countries

19 establishments in 6 countries are registered with the FDA to make Wire, Guide, Catheter, Exempt (product code PTL, Class 2, 21 CFR 870.1330). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
PTL
Device class
2
Regulation
870.1330
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States8
China5
India3
Costa Rica1
Ireland1
Germany1

Makers of Wire, Guide, Catheter, Exempt

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Advanced Lifesciences Pvt. Ltd.New Delhi, IndiaExporter to the US, Manufacturer0000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer0000api.fda.gov
Dynaflex TechnologiesIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Epflex Feinwerktechnik GMBHDETTINGEN/ERMS Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Gilero, IncPittsboro, NC, United StatesContract manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Invamed, Inc.New York, NY, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Jacobs Institute, Inc.Buffalo, NY, United StatesSpecification developer0000api.fda.gov
Lepu Medical Technology (beijing) Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Lepu Medical Technology (beijing) Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nolato GW BETHELBethel, VT, United StatesContract manufacturer0000api.fda.gov
Sunny Medical Device (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shanghai INT Medical Instruments Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Terumo Medical Products (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.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.