# K972555: Catheter Tunneler

- Pathway: 510(k) (Traditional)
- Applicant: Gerard Medical, Inc.
- Decided: Dec 22, 1997 after 168 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) Catheter Tunneler. Manufactured by Bard Access Systems (Division of C.R. Bard, Inc.): named in the summary without a submission number

## Indications for use
A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted catheter. The implanting surgeon would oftentimes utilize the tunneler when implanting our TrimPort Systems. Our TrimPort Implantable Port Systems are indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

Source page: https://510kreport.com/device/K972555
Methodology: https://510kreport.com/methodology