Atlas FDA

DUAL LUMEN CATHETER

FDA 510(k) clearance K043581 · decided 2005-03-03

Clearance details

K-number
K043581
Device name
DUAL LUMEN CATHETER
Applicant
Acmi Corporation
Decision
Substantially Equivalent
Date received
2004-12-28
Decision date
2005-03-03
Days to decision
65 days
Clearance type
Special
Product code
EYB
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Southborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single recall (Z-2226-2008)Gyrus ACMI Corporation2008-09-16