# K030400: Neosci Medical Endoluminal Brush

- Pathway: 510(k) (Traditional)
- Applicant: Neosci Medical, Inc.
- Decided: Dec 22, 2004 after 685 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FAS Endoluminal Brush: named in the summary without a submission number
- (no number) Digene Cervical Brush: named in the summary without a submission number
- (no number) Guidant Hi-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating: named in the summary without a submission number
- (no number) AngioDynamics Continuous Flush Catheter of its Pulse Spray Infusion System: named in the summary without a submission number
- (no number) Gait Medical Guide Wire: named in the summary without a submission number

## Indications for use
The NeoSci Medical Endoluminal Brush is intended to collect a sample, which is suitable for microbiological analysis, from the inner lumen surface of an indwelling central venous catheter. The proximal nitinol shaft is encased in a polytetrafluoroethylene sheath with a hydrophilic coating applied to reduce friction. The device is contraindicated for patients with known, or suspected, allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold, or hydrophilic coatings.

Source page: https://510kreport.com/device/K030400
Methodology: https://510kreport.com/methodology