|
Device |
shunt, central nervous system and components |
Product Code | JXG |
Regulation Number |
882.5550
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AESCULAP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
ALCYONE LIFESCIENCES. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANUNCIA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AQUEDUCT CRITICAL CARE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AQUEDUCT CRITICAL CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ARKIS BIOSCIENCES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTG INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
1. K090348 CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEA ...
|
2. K091346 CODMAN HAKIM MICRO II VALVE
|
3. K102589 CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD C ...
|
4. K102961 HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHE ...
|
5. K110751 CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
|
6. K122118 HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTE ...
|
7. K162437 Codman EDS3 CSF External Drainage System
|
8. K172022 CODMAN Hydrocephalus Valves, Catheters & Accessori ...
|
9. K172537 Codman EDS 3 CSF External Drainage System, Codman ...
|
INTEGRA LIFESCIENCES CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IRRAS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRRAS USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRRAS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IRRAS USA, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JMED(SHENZHEN) TECHNOLOGY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC NEUROSURGERY |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MOLLER MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEURODX DEVELOPMENT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOPHYSA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOPHYSA SA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Integra Neuro Sciences |
II |
Sep-08-2009 |
2 |
Aesculap Implant Systems LLC |
II |
Mar-01-2018 |
3 |
Aesculap, Inc. |
II |
Jan-26-2015 |
4 |
Aesculap, Inc. |
III |
Dec-16-2014 |
5 |
Aesculap, Inc. |
II |
Dec-03-2014 |
6 |
Aesculap, Inc. |
II |
Jun-02-2014 |
7 |
Aesculap, Inc. |
II |
Feb-19-2014 |
8 |
Aesculap, Inc. |
II |
Feb-12-2013 |
9 |
Codman & Shurtleff, Inc. |
II |
Oct-20-2014 |
10 |
Codman & Shurtleff, Inc. |
II |
Aug-12-2014 |
11 |
Codman & Shurtleff, Inc. |
II |
Apr-17-2014 |
12 |
Codman & Shurtleff, Inc. |
II |
Jan-29-2014 |
13 |
Integra LifeSciences Corp |
II |
Jul-10-2012 |
14 |
Integra LifeSciences Corp. |
II |
Dec-23-2020 |
15 |
Integra LifeSciences Corp. |
I |
May-20-2019 |
16 |
Integra LifeSciences Corp. |
II |
Sep-30-2016 |
17 |
Integra LifeSciences Corp. |
II |
Jan-03-2014 |
18 |
Integra LifeSciences Corp. d.b.a. Integra Pain Management |
II |
Dec-20-2013 |
19 |
Integra Neurosciences PR, Inc. |
II |
Feb-16-2012 |
20 |
Medtronic Neurosurgery |
II |
Aug-17-2023 |
21 |
Medtronic Neurosurgery |
II |
Feb-12-2021 |
22 |
Medtronic Neurosurgery |
II |
Jan-15-2021 |
23 |
Medtronic Neurosurgery |
II |
Dec-28-2020 |
24 |
Medtronic Neurosurgery |
I |
Apr-07-2017 |
25 |
Medtronic Neurosurgery |
II |
Feb-02-2017 |
26 |
Medtronic Neurosurgery |
I |
Jun-27-2014 |
27 |
Medtronic Neurosurgery |
II |
Nov-26-2013 |
28 |
Medtronic Neurosurgery |
I |
Mar-27-2009 |
29 |
Natus Manufacturing Limited |
II |
Feb-22-2021 |
30 |
Natus Medical Incorporated |
II |
Jan-04-2024 |
|
|
|
|