Lexion Medical, LLC.
Saint Paul, MN, US
LEXION MEDICAL, LLC. appears in FDA device records in Saint Paul, MN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Lexion Medical, LLC. between 2007 and 2019. The busiest year on record is 2009, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191780 | AP50/30 Insufflator with Insuflow Port | HIF | Substantially Equivalent | |
| K170799 | AP 50/30 Insufflator with Insuflow Port | HIF | Substantially Equivalent | |
| K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | HIF | Substantially Equivalent | |
| K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | HIF | Substantially Equivalent | |
| K132204 | INSUFLOW SYNERGY XL PORT | HIF | Substantially Equivalent | |
| K120640 | INSUFLOW SYNERGY PORT | HIF | Substantially Equivalent | |
| K112357 | VESSEL GUARDIAN | HIF | Substantially Equivalent | |
| K102136 | VESSEL GUARDIAN | HIF | Substantially Equivalent | |
| K101320 | VASOVAPOR | HIF | Substantially Equivalent | |
| K091366 | INSUFLOW DEWHEART | HIF | Substantially Equivalent | |
| K090456 | INSUFLOW | HIF | Substantially Equivalent | |
| K090879 | INSUFLOW CO2IONSHIELD | FCX | Substantially Equivalent | |
| K063546 | INSUFLOW DEVICE, MODEL 6198 | HIF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2135348 | 3003631551 | LEXION MEDICAL, LLC. | 545 Atwater Cir, Saint Paul, MN 55103 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain