Class Class II
Micro Ace Gold Advanced Micro Access System (K242229)
Description
Micro Ace Gold Advanced Micro Access System by Merit Medical Systems, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242229
Clearance Date2025-01-15
Clearance TypeTraditional
Product CodeDRE
Regulation Number870.1310
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242229
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Micro Ace Gold Advanced Micro Access System (K242229) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232609 | Micro AceĀ Advanced Micro Access System | Merit Medical Systems, Inc. | 2023 |
Trace the full predicate network for K242229
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.