# K971799: Precision Flow Osv II

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Implants, SA
- Decided: Feb 6, 1998 after 267 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: 1 generation back to K913636 (1991). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913636: Orbis-Sigma Valve System for Ventricular Shunting, Cordis Corp. (1991) Summary page 2.
- (no number) Cordis Omnishunt® System: named in the summary without a submission number
- (no number) Cordis Polypropylene Connectors: named in the summary without a submission number
- (no number) Cordis Ventricular Antechamber: named in the summary without a submission number
- (no number) Cordis Straight or Finned Ventricular Catheters (with radiopaque dots): named in the summary without a submission number

## Most influential descendants
- K042192: Low Flow Osv II Hydrocephalus Valve (2004), 3 descendants of its own
- K081773: OSV II (2008), 2 descendants of its own
- K093968: Osv II Low Flow Low Pro Valve (2010), 1 descendant of its own
- K092395: Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System (2009), 1 descendant of its own
- K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models (2015), 0 descendants of its own

## Indications for use
The Precision Flow OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Source page: https://510kreport.com/device/K971799
Methodology: https://510kreport.com/methodology