510(k) clearances

EDEN ControlCath

Jmt Co., Ltd. · Anesthesiology

K241410Substantially EquivalentTraditionalBSO
Open FDA's page for this record
Third party flag
N
City
Yangju-Si
Advisory committee description
Anesthesiology
Address 1
70-39, Gwonyul-Ro 1203beon-Gil, Baekseok-Eup
Statement or summary
Summary
Product code
BSO
Zip code
11517
Applicant
Jmt Co., Ltd.
Decision date
2025-02-13
Decision code
SESE
Country code
KR
Device name
EDEN ControlCath
Advisory committee
AN
Contact
Sang-Ok Nam
K number
K241410
Date received
2024-05-17
Review advisory committee
AN
Postal code
11517
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Conduction, Anesthetic
Medical specialty description
Anesthesiology
Regulation number
868.5120
Device class
2
Registration number
3003898360, 3016678045, 2025816, 1417592, 9680425, 3015972753, 3009888344, 2030624, 3009039068, 1018470, 3010170586, 1043214, 3002806603, 3003767927, 3007441619, 1061124, 3014656749, 3006425876, 3006946348, 3009599228, 3015460875, 3013162291, 2134812, 3010321647, 3021006165, 1644312, 3010041511, 2521402, 3003915875, 3011137372, 3015443199, 3006188722, 3013764800, 1319639, 9611612, 3011270181, 9617604, 1423507, 2618282, 9680794 +15 more
FEI number
3002806469, 3003898360, 3016678045, 2025816, 1417592, 3002558692, 3015972753, 3009888344, 3009039068, 1000512168, 1018470, 3010170586, 3003737899, 1043214, 3007596547, 3002806603, 3003767927, 3002807847, 3007441619, 3014656749, 3006425876, 3006946348, 3009599228, 1000306431, 3015460875, 3013162291, 3021006165, 3010321647, 3010041511, 2521402, 3003915875, 3000206435, 3015443199, 3006188722, 2649711, 1000117748, 3013764800, 3011270181, 3002827704, 3008002452 +15 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.