MedtechSourcebook

Catheter For Crossing Total Occlusions (PDU) contract manufacturers

17 US facilities list FDA product code PDU as a contract manufacturer (5) or contract sterilizer (12).

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

FDA device name
Catheter For Crossing Total Occlusions
Product code
PDU (FDA product classification database)
Device class
Class II
Regulation
21 CFR 870.1250
Classification panel
Cardiovascular

Where they are

Utah 3 · California 2 · Georgia 2 · Minnesota 2 · New York 2 · Pennsylvania 2 · Colorado 1 · Illinois 1 · New Hampshire 1 · Texas 1

All 17 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
BIOMERICS3008998256Contract manufacturerCardiovascular; Gastroenterology and urology; General hospital +3 moreSalt Lake City, UTNot verifiedOct 21, 2026
C.R. BARD, INC.1018233Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreCovington, GANot verifiedOct 21, 2026
C.R. BARD, INC.1313046Contract manufacturerCardiovascular; Gastroenterology and urology; General hospital +1 moreQueensbury, NYNot verifiedOct 21, 2026
C.R. BARD, INC.3006082230Contract sterilizerGastroenterology and urology; Cardiovascular; General and plastic surgery +4 moreMadison, GANot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations, Inc.1450662Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +11 moreLibertyville, ILNot verifiedOct 21, 2026
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
Lake Region Medical2126666Contract manufacturerCardiovascular; Ophthalmic; Neurology +3 moreChaska, MNNot verifiedOct 21, 2026
LYNX Medical Pennsylvania2528981Contract sterilizerOrthopedic; Gastroenterology and urology; Cardiovascular +8 moreErie, PANot verifiedOct 21, 2026
MEDRON, LLC1722746Contract manufacturerGastroenterology and urology; Cardiovascular; General hospital +3 moreSalt Lake City, UTNot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026
Sterigenics U.S., LLC1721676Contract sterilizerCardiovascular; Orthopedic; General and plastic surgery +12 moreSalt Lake City, UTNot verifiedOct 21, 2026
Sterigenics US LLC2011171Contract sterilizerCardiovascular; General and plastic surgery; General hospital +13 moreLos Angeles, CANot verifiedOct 21, 2026
Synergy Health AST, LLC2030598Contract sterilizerGeneral and plastic surgery; Cardiovascular; Clinical chemistry +10 moreSan Diego, CANot verifiedOct 21, 2026
Synergy Health AST, LLC3009882464Contract sterilizerGeneral and plastic surgery; Cardiovascular; Clinical chemistry +6 moreSaxonburg, PANot verifiedOct 21, 2026
Terumo BCT STERILIZATION SERVICES, Inc.1724474Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +6 moreLakewood, CONot verifiedOct 21, 2026
Viant AS&O Holdings, LLC1221485Contract manufacturerNeurology; Cardiovascular; Ear, nose and throat +6 moreLaconia, NHNot verifiedOct 21, 2026

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