510(k) clearances

AXS Lift Intracranial Base Catheter

Stryker Neurovascular · Cardiovascular

K243593Substantially EquivalentTraditionalQJP
Open FDA's page for this record
Third party flag
N
City
Fremont
Advisory committee description
Cardiovascular
Address 1
47900 Bayside Pkwy.
Statement or summary
Summary
Product code
QJP
Zip code
94538
Applicant
Stryker Neurovascular
Decision date
2025-02-18
Decision code
SESE
Country code
US
Device name
AXS Lift Intracranial Base Catheter
Advisory committee
CV
Contact
Natalie Allen
K number
K243593
State
CA
Date received
2024-11-20
Review advisory committee
NE
Postal code
94538
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Percutaneous, Neurovasculature
Medical specialty description
Cardiovascular
Regulation number
870.1250
Device class
2
Registration number
3013656790, 3017278832, 3015550451, 3015615738, 3012543881, 3025028711, 3008264254, 2030624, 1048735, 3013858269, 3020954126, 3006451981, 3015453963, 3031311812, 3006010712, 3009965866, 3010079067, 3017210488, 3009337401, 3017168767, 3008837339, 3003775027, 2183744, 3019807891, 3013556777, 2029214, 3014766734, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 3014779787, 3013944123, 3004063494, 3032047719, 3013758550, 3015701715, 1035166 +36 more
FEI number
3013656790, 3017278832, 3015550451, 3015615738, 3012543881, 3025028711, 3008264254, 1048735, 3013858269, 3020954126, 3006451981, 3015453963, 3031311812, 3006010712, 3009965866, 3010079067, 3017210488, 3009337401, 3017168767, 3008837339, 3003775027, 2183744, 3003495548, 3013556777, 3019807891, 3014766734, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 3014779787, 3013944123, 3004063494, 3032047719, 3013758550, 3015701715, 1035166, 1047843 +36 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.