AMP DIRECT VASCULAR MONITORING SYSTEM

K792646 · American Medical Products, Inc. · KRH · Feb 11, 1980 · Cardiovascular

Device Facts

• Record ID: K792646
• Device Name: AMP DIRECT VASCULAR MONITORING SYSTEM
• Applicant: American Medical Products, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Feb 11, 1980
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”