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Data / Medical devices / Catheter, Percutaneous, Cutting/Scoring

Catheter, Percutaneous, Cutting/Scoring (PNO): 19 FDA-registered makers in 5 countries

19 establishments in 5 countries are registered with the FDA to make Catheter, Percutaneous, Cutting/Scoring (product code PNO, Class 2, 21 CFR 870.1250). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on October 22, 2026, and lists 1 recall event (1 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
PNO
Device class
2
Regulation
870.1250
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States11
China3
Japan3
Ireland1
Malaysia1

Makers of Catheter, Percutaneous, Cutting/Scoring

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
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer2September 22, 2017000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer, Specification developer2June 10, 2015000api.fda.gov
DK Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer2April 21, 2025000api.fda.gov
Nipro Vascular CorporationNagoya Aichi, JapanManufacturer2April 22, 2025000api.fda.gov
NIPRO VASCULAR CORPORATION Aichi FacilitySeto Aichi, JapanManufacturer2April 22, 2025000api.fda.gov
NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation CenterSeto Aichi, JapanSpecification developer2April 22, 2025000api.fda.gov
OrbusNeich Medical (Shenzhen) Co., Ltd.SHENZHEN Guangdong, ChinaComplaint file establishment, Manufacturer2September 16, 2026000api.fda.gov
VENTUREMED GROUP, IncPlymouth, MN, United StatesComplaint file establishment, Specification developer2September 11, 2020000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer2June 17, 2024000api.fda.gov
Brosmed Medical Co.,ltdDongguan Guangdong, ChinaManufacturer, Specification developer1October 22, 2024000api.fda.gov
Cagent VascularWayne, PA, United StatesComplaint file establishment, Specification developer1April 15, 2020000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1March 27, 2015011api.fda.gov
Spectranetics Corp.Fremont, CA, United StatesComplaint file establishment, Manufacturer1April 8, 2015000api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
Brosmed Medical (malaysia) Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Meraqi Medical, Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.fda.gov

Updated October 22, 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.