510(k) clearances

React 71 Catheter

Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · Cardiovascular

K241177Substantially EquivalentSpecialDQY
Open FDA's page for this record
Third party flag
N
City
Irvine
Advisory committee description
Cardiovascular
Address 1
9775 Toledo Way
Statement or summary
Summary
Product code
DQY
Zip code
92612
Applicant
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Decision date
2024-05-28
Decision code
SESE
Country code
US
Device name
React 71 Catheter
Advisory committee
CV
Contact
Alexander Abe
K number
K241177
State
CA
Date received
2024-04-29
Review advisory committee
NE
Postal code
92612
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Catheter, Percutaneous
Medical specialty description
Cardiovascular
Regulation number
870.1250
Device class
2
Registration number
3016704395, 2648045, 3012543881, 3000268902, 3027058844, 2953200, 1313046, 3009766315, 3016829855, 3020954746, 3009018440, 3012159165, 3025341484, 3008837339, 2025870, 3019807891, 3002806603, 3007695959, 3006946276, 3027319104, 9617592, 3008881809, 1061124, 3006425876, 2017865, 3005334138, 3035111606, 3008110587, 2134812, 2024168, 1722746, 3008114965, 3016591327, 3009756153, 3004111573, 3016522967, 2030598, 3011137372, 3015002281, 3033589330 +238 more
FEI number
3016704395, 2648045, 3012543881, 3000268902, 3027058844, 1313046, 3009766315, 2828, 3016829855, 3002806565, 3009018440, 3012159165, 3020954746, 3002807036, 3025341484, 3002755653, 3008837339, 2025870, 3019807891, 3002806603, 3007695959, 3006946276, 3027319104, 3008881809, 3006425876, 2017865, 3005334138, 3035111606, 3008110587, 2024168, 3008114965, 3016591327, 3009756153, 3004111573, 3016522967, 3015002281, 3033589330, 3000206435, 3046434506, 1000116158 +237 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.