Class Class II
Morph DNA Steerable Introducer Sheath (K242169)
Description
Morph DNA Steerable Introducer Sheath by Biocardia, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242169
Clearance Date2024-08-23
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242169
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. Morph DNA Steerable Introducer Sheath (K242169) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | Biocardia | 2020 |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | 2019 |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | Biocardia, Inc. | 2009 |
Trace the full predicate network for K242169
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.