MedtechSourcebook

Catheter, Septostomy (DXF) contract manufacturers

11 US facilities list FDA product code DXF as a contract manufacturer (4) or contract sterilizer (7).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Catheter, Septostomy
Product code
DXF (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.5175
Classification panel
Cardiovascular

Where they are

California 2 · Illinois 2 · Minnesota 2 · Massachusetts 1 · New Jersey 1 · New York 1 · Pennsylvania 1 · South Carolina 1

All 11 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ACCUMEDIX, INC.1424785Contract manufacturerDental; Obstetrics and gynecology; General and plastic surgery +6 moreLibertyville, ILNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1047843Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Orthopedic +13 moreSpartanburg, SCNot verifiedOct 21, 2026
Isomedix Operations Inc.2246552Contract sterilizerGeneral and plastic surgery; Orthopedic; Gastroenterology and urology +12 moreS Plainfield, NJNot verifiedOct 21, 2026
Isomedix Operations, Inc.1424263Contract sterilizerOrthopedic; General and plastic surgery; Ophthalmic +13 moreLibertyville, ILNot verifiedOct 21, 2026
Isomedix Operations, Inc.2030624Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +11 moreTemecula, CANot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
LYNX Medical Pennsylvania2528981Contract sterilizerOrthopedic; Gastroenterology and urology; Cardiovascular +8 moreErie, PANot verifiedOct 21, 2026
Lake Region Medical2126666Contract manufacturerCardiovascular; Ophthalmic; Neurology +3 moreChaska, MNNot verifiedOct 21, 2026
PATHWAY MEDTECH, LLC.3012833053Contract manufacturerCardiovascular; Gastroenterology and urology; General hospital +2 moreSantee, CANot verifiedOct 21, 2026
Primo Medical Group, Inc3009420598Contract manufacturerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +10 moreW Bridgewater, MANot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026

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