Data / Medical devices / Catheter Introducer Kit

Catheter Introducer Kit (OFC): 17 FDA-registered makers in 5 countries

Name: FDA-registered makers of Catheter Introducer Kit
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 5 countries are registered with the FDA to make Catheter Introducer Kit (product code OFC, Class 2, 21 CFR 870.1340). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 26, 2010, and lists 3 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code: OFC
Device class: 2
Regulation: 870.1340
Medical specialty: Cardiovascular

Makers by country

Country	Makers
United States	11
Mexico	3
China	1
Switzerland	1
Germany	1

Makers of Catheter Introducer Kit

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.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Spectranetics Corp.	Colorado Springs, CO, United States	Complaint file establishment, Manufacturer, Specification developer	1	March 26, 2010	0	api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.	Chihuahua, Mexico	Manufacturer	0		0	api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, United States	Specification developer	0		0	api.fda.gov
Cardinal Health 200, LLC	El Paso, TX, United States	Manufacturer	0		0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	Manufacturer	0		0	api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.	JIAXING Zhejiang, China	Manufacturer	0		0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
PFM Medical, Inc	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Prytime Medical Devices, Inc.	Lakewood, CO, United States	Specification developer	0		0	api.fda.gov
Prytime Medical Devices, Inc.	Boerne, TX, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Vascular Solutions LLC	Maple Grove, MN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Vygon Usa	Lansdale, PA, United States	Specification developer	0		0	api.fda.gov
Vygon MFG	Dover, NH, United States	Manufacturer	0		0	api.fda.gov
Zien Medical Technologies LLC	Salt Lake City, UT, United States	Manufacturer	0		0	api.fda.gov
pfm medical cpp SA	LA CHAUX-DE-FONDS Neuchatel, Switzerland	Contract manufacturer	0		0	api.fda.gov
pfm medical mepro gmbh	Nonnweiler-Otzenhausen Saarland, Germany	Contract manufacturer	0		0	api.fda.gov

Updated March 26, 2010. 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.