Class Class II
Catheter Surface Flap Applicator Set (GM11011830) (K241965)
Description
Catheter Surface Flap Applicator Set (GM11011830) by Varian Medical Systems, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241965
Clearance Date2024-10-29
Clearance TypeTraditional
Product CodeJAQ
Regulation Number892.5700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241965
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. Catheter Surface Flap Applicator Set (GM11011830) (K241965) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | 2025 |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak... | Varian Medical Systems, Inc. | 2015 |
Trace the full predicate network for K241965
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.