Product code DTA— Cardiovascular

FDA has cleared 10 devices under product code DTA between 1979 and 2017, 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.

• 20171 clearance
• 20101 clearance
• 20071 clearance
• 20051 clearance
• 20032 clearances
• 19931 clearance
• 19811 clearance
• 19792 clearances

• Biotronik, Inc.3 clearances
• Vitatron Medical BV1 clearance
• St Jude Medical, Crmd1 clearance
• Siemens Corp.1 clearance
• Remington Medical, Inc.1 clearance
• Medtronic, Inc.1 clearance
• Ep Medical, Inc.1 clearance
• Cardiac Pacemakers, Inc.1 clearance

• K163008 — CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc.·2017-02-28
• K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180St Jude Medical, Crmd·2010-12-21
• K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERSBiotronik, Inc.·2007-12-20
• K050884 — ADAPTER CABLERemington Medical, Inc.·2005-05-19
• K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.·2003-12-08
• K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.Biotronik, Inc.·2003-01-27
• K933069 — MODEL EP-2 CLINICAL STIMULATOREp Medical, Inc.·1993-10-21
• K812104 — SIEMENS-ELEMA PSA 376Siemens Corp.·1981-12-02
• K791380 — VA 1000Vitatron Medical BV·1979-09-19
• K790503 — CARDIOTEST 2200Cardiac Pacemakers, Inc.·1979-05-17