Product code MOP— Cardiovascular

FDA has cleared 4 devices under product code MOP between 1995 and 1998, filed by 3 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.

• 19982 clearances
• 19961 clearance
• 19951 clearance

• Carbomedics, Inc.2 clearances
• Sulzer Carbomedics, Inc.1 clearance
• Genzyme Surgical Product (Genzyme Biosurgery)1 clearance

• K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEGenzyme Surgical Product (Genzyme Biosurgery)·1998-08-07
• K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATORSulzer Carbomedics, Inc.·1998-08-04
• K960923 — CARBOMEDICS MITRAL ROTATORCarbomedics, Inc.·1996-04-29
• K951368 — CARBOMEDICS EXENDED MITRAL ROTATORCarbomedics, Inc.·1995-06-20