510(k) clearances

CEREGLIDE 92 Catheter System

Cerenovus, Inc. · Cardiovascular

K233982Substantially EquivalentSpecialQJP
Open FDA's page for this record
Third party flag
N
City
Miami
Advisory committee description
Cardiovascular
Address 1
6303 Waterford District Dr., Suites 215 & 315
Statement or summary
Summary
Product code
QJP
Zip code
33126
Applicant
Cerenovus, Inc.
Decision date
2024-05-09
Decision code
SESE
Country code
US
Device name
CEREGLIDE 92 Catheter System
Advisory committee
CV
Contact
Niall Fox
K number
K233982
State
FL
Date received
2023-12-18
Review advisory committee
NE
Postal code
33126
Decision description
Substantially Equivalent
Clearance type
Special
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
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.