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U.S. Department of Health and Human Services

Product Classification

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Device clamp, dialysis arm
Regulation Description Blood access device and accessories.
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 Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNOO
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type 510(K) Exempt
Regulation Number 876.5540
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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