# K971613: Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Technical Products, Inc.
- Decided: May 22, 1997 after 20 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application Applications for Tubing include: 1. Silicone tubing has been used in artificial external or internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arteriovenous system Blood transfusions Suction drainage of surgical wounds Temporary tube gastrostomy following abdominal surgery Connecting glass tubing of different bores

Source page: https://510kreport.com/device/K971613
Methodology: https://510kreport.com/methodology