XPOSE 4 Access Device

Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  ACROBAT V Off Pump Vacuum Stabilizer OM-9100S  25038623, 25039921, 25040646, 25041091, 25042446, 25042522  ACROBAT SUV Off Pump Vacuum Stabilizer OM-9000S  25035819, 25037049, 25037461, 25037587, 25037871, 25037986, 25038109, 25038366, 25038500, 2503853, 25038947, 25039317, 25039450, 25039769, 25040040, 25040124, 25040530, 25040864, 25040945, 25041319, 25041599, 25041689, 25041954, 25042126, 25042237  ACROBAT Off Pump Mechanical Stabilizer OM-6000S  25040360, 25042190

Cardiovascular Devices

1

No

Worldwide Distribution - USA Nationwide

ACROBAT Stabilizers- || ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  AXIUS XPOSE 3 Off Pump Positioner XP-3000   25037165, 25037244, 25038989, 25040320, 25040776   XPOSE 4 Off Pump Positioner XP-4000   25037059, 25037396, 25037447, 25037894, 25038001, 25038376, 25038550, 25038874, 25039267, 25039158, 25039455, 25039915, 25040060, 25040465, 25040617, 25040866, 25041058, 25041248, 25041714, 25041606, 25042076, 25042550

Cardiovascular Devices

1

No

Worldwide Distribution - USA Nationwide

XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.