AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514)
Description
AMT Low-Profile Suprapubic Catheter & Drainage Set by Applied Medical Technology, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240514
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. AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 |
| K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 |
Trace the full predicate network for K240514
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.