Known Identifiers & Locations
FEI Numbers
N/A
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (3)
| Submission # |
Device Name |
Decision Date |
Decision Description |
Action |
| K162925 |
AcQGuide Steerable Sheath |
2017-04-06 |
Substantially Equivalent |
View Details
|
| K170948 |
AcQMap High Resolution Imaging and Mapping System |
2017-10-16 |
Substantially Equivalent |
View Details
|
| K233691 |
FlexCath Cross Transseptal Solution |
2023-12-17 |
Substantially Equivalent |
View Details
|
FDA Recall History (0)
No recall records found for this entity.
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.