Class Class II
ProTrack Pigtail Wire (K213898)
Description
ProTrack Pigtail Wire by Baylis Medical Company, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213898
Clearance Date2023-03-01
Clearance TypeTraditional
Product CodeDQX
Regulation Number870.1330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213898
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. ProTrack Pigtail Wire (K213898) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K132623 | MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE | Medtronic | 2013 |
Trace the full predicate network for K213898
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.