AP50/30 Insufflator With Insuflow Port
Lexion Medical LLC
LEXION MEDICAL, LLC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2135348 | 3003631551 | LEXION MEDICAL, LLC. | 1 | N | 2026-01-01 | 545 Atwater Cir Saint Paul MN US 55103 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 58555 | 1922000563 | K191780 | AP50/30 Insufflator with Insuflow Port | HIF | 2019-08-28 |
| 58555 | 1311632653 | K170799 | AP 50/30 Insufflator with Insuflow Port | HIF | 2017-11-14 |
| 58555 | 1161069665 | K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | HIF | 2014-03-05 |
| 58555 | 1125174223 | K132204 | INSUFLOW SYNERGY XL PORT | HIF | 2013-08-22 |
| 58555 | 1739286858 | K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | HIF | 2013-09-20 |
| 58555 | 1545093419 | K120640 | INSUFLOW SYNERGY PORT | HIF | 2012-07-18 |
| 58555 | 1872353269 | K102136 | VESSEL GUARDIAN | HIF | 2010-09-27 |
| 58555 | 1637213038 | K091366 | INSUFLOW DEWHEART | HIF | 2009-09-03 |
| 58555 | 1225245928 | K063546 | INSUFLOW DEVICE, MODEL 6198 | HIF | 2007-01-10 |
| 58555 | 1077669518 | ||||
| 58555 | 1917593047 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HIF | 9 | 2019-08-28 |
PMN#
AP 50/30 Insufflator With Insuflow Port
LEXION Medical LLC
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
LEXION MEDICAL, LLC.
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
LEXION MEDICAL, LLC.
INSUFLOW SYNERGY XL PORT
LEXION MEDICAL, LLC.
INSUFLOW SYNERGY PORT
LEXION MEDICAL, LLC.
VESSEL GUARDIAN
LEXION MEDICAL, LLC.
VESSEL GUARDIAN
LEXION MEDICAL, LLC.
VASOVAPOR
LEXION MEDICAL, LLC.
INSUFLOW DEWHEART
LEXION MEDICAL, LLC.
INSUFLOW
LEXION MEDICAL, LLC.
INSUFLOW CO2IONSHIELD
LEXION MEDICAL, LLC.
INSUFLOW DEVICE, MODEL 6198
LEXION MEDICAL, LLC.
GUDID#
AP50/30 - High Flow Insufflator
2020-11-02
Insuflow - Laparoscopic gas conditioning device
2017-02-15
INSUFLOW - LAPAROSCOPIC GAS CONDITIONING DEVICE
2017-02-15
VERYCLEAR - SINGLE LUMEN GAS EVACUATION PORT
2017-02-15
INSUFLOW SYNERGY PORT - 5mm GAS CONDITIONING PORT
2017-02-15
INSUFLOW SYNERGY XL PORT - 8mm GAS CONDITIONING PORT
2017-02-15
INSUFLOW SYNERGY XL PORT - 10mm GAS CONDITIONING PORT
2017-02-15
INSUFLOW SYNERGY XL PORT - 12mm GAS CONDITIONING PORT
2017-02-15
INSUFLOW SYNERGY XL PORT - 8mm X 130mm GAS CONDITIONING PORT
2017-02-15
iNSUFLOW SYNERGY XL PORT - 10mm X 130mm GAS CONDITIONING PORT
2017-02-15
INSUFLOW SYNERGY XL PORT - 12mm X 130mm GAS CONDITIONING PORT
2017-02-15
Standard filtered tube set - Standard insufflation tube set, filtered, single use
2020-11-05
Insuflow Port - 5mm x 100mm Insuflow Port
2020-11-05
Insuflow Port - 8mm x 100mm Insuflow Port
2020-11-05
Insuflow Port - 8mm x 130mm Insuflow Port
2020-11-05
Insuflow Port - 10mm x 100mm Insuflow Port
2020-11-05
Insuflow Port - 10mm x 130mm Insuflow Port
2020-11-05
Insuflow Port - 12mm x 100mm Insuflow Port
2020-11-05
Insuflow Port - 12mm x 130mm Insuflow Port
2020-11-05
Insuflow Port - 5mm x 130mm Insuflow Port
2020-11-05
INSUFLOW - LAPAROSCOPIC GAS CONDITIONING DEVICE
2017-02-15
PNEUVIEW XE - LAPAROSCOPIC SMOKE ELIMINATION DEVICE
2017-02-15
VESSEL GUARDIAN - LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE
2017-02-15
PNEUVIEW XE - LAPAROSCOPIC SMOKE ELIMINATION DEVICE
2017-02-15
Insuflow - Laparoscopic gas conditioning device.
2016-09-26