Atlas FDA

REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

FDA 510(k) clearance K100254 · decided 2010-05-28

Clearance details

K-number
K100254
Device name
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
Applicant
Ascent Healthcare Solutions
Decision
Substantially Equivalent
Date received
2010-01-28
Decision date
2010-05-28
Days to decision
120 days
Clearance type
Traditional
Product code
NLH
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Phoenix, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2174-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2175-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2176-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic Tip Steerable, Product Number 6DYNTP001; recall (Z-2177-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHE recall (Z-2178-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2179-2026)Stryker Sustainability Solutions2026-05-13
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2180-2026)Stryker Sustainability Solutions2026-05-13
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHE recall (Z-2181-2026)Stryker Sustainability Solutions2026-05-13
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2182-2026)Stryker Sustainability Solutions2026-05-13
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2183-2026)Stryker Sustainability Solutions2026-05-13
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHET recall (Z-2184-2026)Stryker Sustainability Solutions2026-05-13
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHET recall (Z-2185-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2186-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2187-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2188-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2189-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2190-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2191-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2192-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2193-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2194-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2195-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2196-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2197-2026)Stryker Sustainability Solutions2026-05-13
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2198-2026)Stryker Sustainability Solutions2026-05-13
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER recall (Z-2199-2026)Stryker Sustainability Solutions2026-05-13