Clamp, Tubing, Blood, Automatic
The Automatic Blood Tubing Clamp is a powered or automated clamp used in hemodialysis circuits to occlude blood tubing in response to alarms or operational conditions, preventing uncontrolled blood flow. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIG, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
Basic Information
- Product Code
- FIG
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093915 | DEKA TAC DEVICE | Aug 23, 2011 | Substantially Equivalent | Deka Research & Development Corp. |
| K921993 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Jan 05, 1994 | Substantially Equivalent | Rocky Mountain Research, Inc. |
| K914459 | AUTOMATIC TUBING CLAMP | Jun 24, 1992 | Substantially Equivalent | Rocky Mountain Research, Inc. |
| K770535 | C-DAK 3500 | Apr 15, 1977 | Substantially Equivalent | Cordis Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.