Product code DXW— Cardiovascular

FDA has cleared 5 devices under product code DXW between 1980 and 1998, filed by 5 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.

• 19981 clearance
• 19961 clearance
• 19803 clearances

• Sphygmetrics, Inc.1 clearance
• Newmed Corp.1 clearance
• Millar Instruments, Inc.1 clearance
• Med-Tek Corp.1 clearance
• Cas Medical Systems, Inc.1 clearance

• K972020 — OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITORCas Medical Systems, Inc.·1998-05-05
• K955887 — NEWMED ABP-LITENewmed Corp.·1996-09-05
• K802830 — MILLAR MIKRO-TIP CATHETER PHONOTRANSMillar Instruments, Inc.·1980-12-10
• K800222 — MODEL 412 ELECTROFLUIDIC MANOMETERMed-Tek Corp.·1980-02-29
• K800179 — INFRASONDE AUTO/INFLATOR ELEC. VIBRATORSphygmetrics, Inc.·1980-02-11