Product code DTS— Cardiovascular

FDA has cleared 9 devices under product code DTS between 1979 and 2006, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20061 clearance
• 19981 clearance
• 19971 clearance
• 19911 clearance
• 19901 clearance
• 19891 clearance
• 19802 clearances
• 19791 clearance

• Gish Biomedical, Inc.2 clearances
• Texas Medical Products, Inc.1 clearance
• Shiley, Inc.1 clearance
• Ohio Medical Products1 clearance
• International Biophysics Corp.1 clearance
• Estech, Inc.1 clearance
• Dlp, Inc.1 clearance
• California Medical Laboratories, Inc.1 clearance

• K053021 — ESTECH CLEARVIEW MV ATRIAL DEPRESSOREstech, Inc.·2006-01-26
• K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.·1998-09-30
• K963756 — IBC CARDIAC SUCTION WARDInternational Biophysics Corp.·1997-11-14
• K905008 — FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.·1991-01-23
• K900339 — HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.·1990-03-28
• K891906 — ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.·1989-06-13
• K801641 — OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products·1980-07-28
• K801400 — DISPOSABLE SUCKER SYSTEMTexas Medical Products, Inc.·1980-06-30
• K791846 — DISPOSSABLE SUCTION TUBE, 6 FRENCHDlp, Inc.·1979-10-02