Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109)
Description
Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241109
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. Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021 |
Trace the full predicate network for K241109
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.