Product code LHX— Cardiovascular

FDA has cleared 4 devices under product code LHX between 1981 and 1995, filed by 4 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.

• 19951 clearance
• 19881 clearance
• 19841 clearance
• 19811 clearance

• Zee Medical Products Co., Inc.1 clearance
• Vinyl Technology, Inc.1 clearance
• Jobst Institute, Inc.1 clearance
• Bp Medical Systems, Inc.1 clearance

• K953763 — GLADIATOR ANTISHOCK PANTSJobst Institute, Inc.·1995-11-28
• K874774 — TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERSVinyl Technology, Inc.·1988-02-08
• K841605 — BP TRAUMA AIR PANTSBp Medical Systems, Inc.·1984-07-06
• K812564 — ZEE LIFE SUPPORT AIR PANTSZee Medical Products Co., Inc.·1981-10-23