ClearanceBrief
510(k) K012708 ยท NLH Catheter, Recording, Electrode, Reprocessed

ELECTROPHYSIOLOGY CATHETER

ApplicantAlliance Medical Corp., Phoenix AZ, US
DecisionSubstantially Equivalent, Aug 13, 2002
ReceivedAug 14, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012708

DateFirm and productCodeLinked 510(k)
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
May 13, 2026Stryker Sustainability Solutions
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Open, Classified		 NLHNone listed
Oct 6, 2016Stryker Sustainability Solutions
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (E
Terminated		 NLHNone listed
Apr 28, 2016Stryker Sustainability Solutions
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mappi
Terminated		 NLHNone listed
Nov 18, 2013Stryker Sustainability Solutions
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 4019
Terminated		 NLHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.