Product code DTG— Cardiovascular

FDA has cleared 5 devices under product code DTG between 1981 and 2009, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20091 clearance
• 19971 clearance
• 19891 clearance
• 19841 clearance
• 19811 clearance

• Pacesetter Systems1 clearance
• Oscor, Inc.1 clearance
• Cyberonics, Inc.1 clearance
• Cardiac Control Systems, Inc.1 clearance
• Cardiac Assist Devices, Inc.1 clearance

• K092364 — MODEL 220 PATIENT MAGNETCyberonics, Inc.·2009-11-03
• K960849 — MAGNO ALARMCardiac Assist Devices, Inc.·1997-03-26
• K895110 — MAESTRO PACEMAKER TEST MAGNETCardiac Control Systems, Inc.·1989-09-26
• K831926 — IMPLANTABLE ENDOCARDIAL PACING LEADSOscor, Inc.·1984-03-12
• K813153 — TEST MAGNETPacesetter Systems·1981-12-02