(20 days)
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 :
- Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system
- 2 Blood transfusions
- Suction drainage of surgical wounds 3
- Temporary tube gastrostomy following abdominal surgery 4
- Connecting glass tubing of different bores 5
Sil-Tec Medical Grade Tubing
This document is a marketing clearance letter from the FDA for a medical device called "Sil-Tec Medical Grade Tubing." It does not contain information about acceptance criteria or a study proving device performance in the way a typical medical device study report would.
Therefore, I cannot provide the requested information. This letter is a regulatory clearance, not a study report.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.