Marian Medical, Inc.
Barbourmeade, KY, US
MARIAN MEDICAL, INC. appears in FDA device records in Barbourmeade, KY. FDA records list 4 510(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 4 510(k) clearances for Marian Medical, Inc. between 2005 and 2007. The busiest year on record is 2005, with 2. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | FCM | Substantially Equivalent | |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | GBM | Substantially Equivalent | |
| K050542 | MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER | LJS | Substantially Equivalent | |
| K042112 | INFANT FEEDING TUBE | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005060859 | 3005060859 | MARIAN MEDICAL, INC. | 3600 Chamberlain Ln Ste 106, Barbourmeade, KY 40241 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