# K961856: Auto Suture Chemosite Tunneler

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jul 18, 1996 after 65 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) Cook™ Trocar Tunnelator™: named in the summary without a submission number
- (no number) Davol® Tunneler: named in the summary without a submission number

## Indications for use
for use with implantable drug delivery ports and catheters and for use in the subcutaneous positioning of long-term vascular access catheters and subcutaneous ports

Source page: https://510kreport.com/device/K961856
Methodology: https://510kreport.com/methodology