FDA.reportPublic FDA data

510(k) K223330

Device
Certas Plus Programmable Valves
Applicant
Integra Lifesciences Production Corporation
510(k) number
K223330
Product code
JXG
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-01
Date received
2022-10-31
Regulation
882.5550
Classification name
Shunt, Central Nervous System And Components
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Amanda Erwin
Address
11 Cabot Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JXG#

510(k), Device, Applicant table
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K251598IntellidropBrainspace, Inc.2025-12-10
K250636Sophy Mini Monopressure Valve (SM1)Sophysa2025-11-28
K252514EVAC-MRIPhasor Health, LLC2025-11-05
K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation2025-08-08
K243552Codman 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)Integra Lifesciences Production Corporation2025-08-06
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa2025-06-20
K243205EVACPhasor Health, LLC2025-06-03
K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery2025-03-10
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.2024-12-16
K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.2024-08-20
K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterIntegra Lifesciences Production Corporation2024-01-17
K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation2023-12-19
K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.2023-10-19
K221694External Drainage SystemJmed(Shenzhen) Technology Limited2023-02-09
K222422Polaris Valve Electronic Reading InstrumentSophysa2023-02-02