510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NOOClass I

Clamp, Dialysis Arm

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NOO is the FDA product code for Clamp, Dialysis Arm, a class I device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NOO
Device name
Clamp, Dialysis Arm
FDA definition
The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.
Regulation
21 CFR 876.5540
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code