Product code DTI— Cardiovascular

FDA has cleared 7 devices under product code DTI between 1980 and 1995, filed by 6 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.

• 19951 clearance
• 19931 clearance
• 19881 clearance
• 19852 clearances
• 19821 clearance
• 19801 clearance

• Carbomedics, Inc.2 clearances
• Medtronic Vascular1 clearance
• Hemex Scientific, Inc.1 clearance
• Hancock Laboratories, Inc.1 clearance
• Celtech1 clearance
• Baxter Healthcare Corp1 clearance

• K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZERCarbomedics, Inc.·1995-11-29
• K934951 — VALVE SIZERCarbomedics, Inc.·1993-12-10
• K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETBaxter Healthcare Corp·1988-05-18
• K853313 — DUROMEDICS CARDIAC VALVE SIZER SETHemex Scientific, Inc.·1985-11-01
• K852612 — METRONIC MODEL F7700 HEART VALVE SIZERSMedtronic Vascular·1985-09-23
• K820887 — MITRAL VALVE ORIFICE SIZERCeltech·1982-07-08
• K801885 — HANCOCK * OBTURATORSHancock Laboratories, Inc.·1980-09-09