WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
Device Facts
| Record ID | K003402 |
|---|---|
| Device Name | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION |
| Applicant | Welcon, Inc. |
| Product Code | JOL · General Hospital |
| Decision Date | May 1, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
