Who is the manufacturer of MEDIASTINAL SILICONE DRAINS?

Sil-Med Corp. submitted the Traditional clearance for MEDIASTINAL SILICONE DRAINS (K942709).

What is the FDA product code for MEDIASTINAL SILICONE DRAINS?

GBW. It is classified under 21 CFR 878.4200 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MEDIASTINAL SILICONE DRAINS?

510(k) clearance (submission type: Traditional).

MEDIASTINAL SILICONE DRAINS

K942709 · Sil-Med Corp. · GBW · Jan 4, 1996 · General, Plastic Surgery

Device Facts

Record ID	K942709
Device Name	MEDIASTINAL SILICONE DRAINS
Applicant	Sil-Med Corp.
Product Code	GBW · General, Plastic Surgery
Decision Date	Jan 4, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 878.4200
Device Class	Class 1

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.