| 2026-06-23 |
K261004 |
Integra Lifesciences Production Corporation
|
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) |
| 2025-12-10 |
K251598 |
Brainspace, Inc.
|
Intellidrop |
| 2025-11-28 |
K250636 |
Sophysa
|
Sophy Mini Monopressure Valve (SM1) |
| 2025-11-05 |
K252514 |
Phasor Health, LLC
|
EVAC-MRI |
| 2025-08-08 |
K243531 |
Integra Lifesciences Production Corporation
|
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology |
| 2025-08-06 |
K243552 |
Integra Lifesciences Production Corporation
|
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) |
| 2025-06-20 |
K242974 |
Sophysa
|
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters |
| 2025-06-03 |
K243205 |
Phasor Health, LLC
|
EVAC |
| 2025-03-10 |
K243676 |
Medtronic Neurosurgery
|
Duet External Drainage and Monitoring System (EDMS) |
| 2024-12-16 |
K242003 |
Aesculap, Inc.
|
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set |
| 2024-08-20 |
K241458 |
Borvo Medical, Inc.
|
Borvo EVAC System (Ergo); Borvo EVAC System (Classic) |
| 2024-01-17 |
K233445 |
Integra Lifesciences Production Corporation
|
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter |
| 2023-12-19 |
K233448 |
Integra Lifesciences Production Corporation
|
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set |
| 2023-10-19 |
K231664 |
Irras USA, Inc.
|
IRRAflow Active Fluid Exchange System (AFES) |
| 2023-02-09 |
K221694 |
Jmed(Shenzhen) Technology Limited
|
External Drainage System |
| 2023-02-02 |
K222422 |
Sophysa
|
Polaris Valve Electronic Reading Instrument |
| 2023-02-01 |
K223330 |
Integra Lifesciences Production Corporation
|
Certas Plus Programmable Valves |
| 2022-12-29 |
K223603 |
Anuncia Medical, Inc.
|
Reflow System Mini and ReFlow Mini Flusher |
| 2022-12-08 |
K222471 |
Irras USA
|
IRRAflow Active Fluid Exchange System (AFES) |
| 2022-10-14 |
K221840 |
Integra Lifesciences Production Corporation
|
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves |
| 2022-09-29 |
K221918 |
Anuncia Medical, Inc.
|
ReFlow System Mini |
| 2021-09-16 |
K212641 |
Medtronic Neurosurgery
|
StrataMR II Valves and Shunts |
| 2020-05-08 |
K200950 |
Aesculap, Inc.
|
Ventricular Catheter |
| 2020-04-29 |
K200807 |
Irras USA, Inc.
|
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |