# K012708: Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Aug 13, 2002 after 364 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891908 (1989). 21 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891908: Bard (R) Tip Deflecting Electrode Catheter, C.R. Bard, Inc. (1989) Summary page 9.
- K971265: Viking Diagnostic Electrode Catheter, C.R. Bard, Inc. (1997) Summary page 9.
- K953663: Cordis Webster T20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1996) Summary page 9.
- K955817: Coridis Webster Deflectable Braided-Tip Electrode Catheter, Cordis Webster, Inc. (1996) Summary page 9.
- K991531: Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078, Cordis Webster, Inc. (1999) Summary page 9.
- K992965: Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085, Cordis Webster, Inc. (1999) Summary page 9.
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220, Biosense Webster, Inc. (2000)
- K914278: Daig Electrophysiology Catheter W/Infusion Lumen, Daig Corp. (1992) Summary page 9.
- K942379: Daig Diagnostic Electrophysiology Catheter, Daig Corp. (1994) Summary page 9.
- K913375: Torque Tube Steerocath (TM), Ep Technologies, Inc. (1991) Summary page 9.
- K924108: Tracfinder II, Ep Technologies, Inc. (1993) Summary page 9.
- K924109: Steerocath II, Ep Technologies, Inc. (1993) Summary page 9.
- K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec, Boston Scientific Corp (1993) Summary page 9.
- K940167: Diagnostic I Catheter, Ep Technologies, Inc. (1994) Summary page 9.
- K940168: Diagnostic II Catheter, Ep Technologies, Inc. (1994) Summary page 9.
- K003452: Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D, Ep Technologies, Inc. (2000)
- K931794: Marinr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1994) Summary page 9.
- K951347: Marinr Series EP Diagnosti Catheters, Medtronic Cardiorhythm (1995) Summary page 9.
- K953185: Platinum Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1996) Summary page 9.
- K964272: Performr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1997) Summary page 9.
- K981642: Stablemapr Steerable Intracardiac Catheters, Medtronic Cardiorhythm (1998) Summary page 9.

## Cited in the summary but kept off the family tree
- K904080: Bard. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 9.
- K912213: Bard. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
- K921872: Bard. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 9.
- K892265: Cordis Webster. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 9.
- K953678: Sterimed Sterization Wrapper (Non-Sterile), Customed, Inc. (1995). Our reading of the summary gave K953678, FDA’s number for Sterimed Sterization Wrapper (Non-Sterile) (Customed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cordis Webster”. Kept off the family tree. Summary page 9.

## Most influential descendants
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K052414: Reprocessed Electrophysiology Catheter (2005), 0 descendants of its own
- K052603: Reprocessed Daig Livewire Electrophysiology Catheters (2005), 0 descendants of its own
- K043392: Reprocessed Electrophysiology Catheters (2005), 0 descendants of its own
- K030026: Reprocessed Electrophysiology Catheter (2003), 0 descendants of its own

## Recalls of this device
- Apr 10, 2026 · Class II · Z-2192-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2196-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2189-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2191-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2185-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2182-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2198-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2195-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2193-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2194-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2183-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2197-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2177-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2186-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2187-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2176-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2175-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2178-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2179-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2181-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2199-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2184-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2180-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2174-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2190-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2188-2026: Incomplete seals on sterile product
- Oct 6, 2016 · Class II · Z-0380-2017: The EP Catheters may be mislabeled for French size during reprocessing.
- Apr 28, 2016 · Class II · Z-1708-2016: Mislabeled for size
- Oct 18, 2013 · Class II · Z-0340-2014: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

## Indications for use
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac seasing, recording, stimulation, and electrophysiological mapping of cardiac structures.

Source page: https://510kreport.com/device/K012708
Methodology: https://510kreport.com/methodology