# K102961: Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors; Accu-Flo Three Way Connector; Codm

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Feb 18, 2011 after 136 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944222 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944222: Codman-Medos Valve Shunt System, Johnson & Johnson Professionals, Inc. (1995) Summary page 2.
- K973774: Codman Hakim Micro Precision Valve, Johnson & Johnson Professionals, Inc. (1997) Summary page 2.
- (no number) CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design: named in the summary without a submission number
- (no number) CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRoy Design: named in the summary without a submission number
- (no number) CODMAN® ACCU-FLO® Straight Connectors: named in the summary without a submission number
- (no number) CODMAN® HOLTER® Type A Fixation and Joining Connector: named in the summary without a submission number
- (no number) CODMAN® HOLTER® Type B Fixation and Joining Connector: named in the summary without a submission number
- (no number) CODMAN® ACCU-FLO® Connector, Three Way: named in the summary without a submission number
- (no number) CODMAN® HOLTER® RICKHAM® Reservoir: named in the summary without a submission number
- (no number) CODMAN® HOLTER® SALMON-RICKHAM® Reservoir: named in the summary without a submission number
- (no number) CODMAN® ACCU-FLO® Right Angle Connectors: named in the summary without a submission number
- (no number) CODMAN® HOLTER® SELKER Reservoir: named in the summary without a submission number

## Indications for use
The Codman-Medos Connector is for use in the treatment of hydrocepha/us as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 mm nominal /.D. silicone rubber tubing with nonabsorbable sutures in a surgical application. The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 mm nominal l.D. silicone rubber tubing to 1.2 mm nominal /.D. silicone rubber tubing, and specifically, catalog no. 82-1672, with nonabsorbable sutures in a surgical application. The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway. The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into the right atrium of the heart or the peritoneal cavity, providing they are used in the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application. The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into the right atrium of the heart or the peritoneal cavity, providing they are used in the joining and fixation of approximately 1.3mm nominal /.D. silicone rubber tubing with nonabsorbable sutures in a surgical application. The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid. The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately 3.9 microns when neoplasrn is suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.

Source page: https://510kreport.com/device/K102961
Methodology: https://510kreport.com/methodology