Clamp, Line
The Line Clamp is a device used to temporarily occlude or regulate flow through IV or dialysis tubing lines during medical procedures. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FKK, regulated under 21 CFR 876.4730 in the Gastroenterology and Urology specialty.
Research product code FKK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FKK
- Device Class
- FDA class 1
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854517 | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET | Dec 02, 1985 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K854512 | TUBING CLAMP CAT#1000-A | Dec 02, 1985 | Substantially Equivalent | Rao Medical Devices, Inc. |
| K844121 | CLAMP, TUBING, LINE | Dec 17, 1984 | Substantially Equivalent | Dyn-A-Med Products |
| K831689 | EMPTY DIALYSATE CONTAINER | Aug 11, 1983 | Substantially Equivalent | Delmed, Inc. |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | Oct 13, 1982 | Substantially Equivalent | American Medical Products, Inc. |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.