Heraeus Medical Components, LLC
Saint Paul, MN, US
HERAEUS MEDICAL COMPONENTS, LLC appears in FDA device records in Saint Paul, MN. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. 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 Heraeus Medical Components, LLC between 2017 and 2019. The busiest year on record is 2017, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191305 | Hereaeus Poseidon Microcatheter | KRA | Substantially Equivalent | |
| K191502 | Heraeus Peripheral Guidewire | DQX | Substantially Equivalent | |
| K170664 | Odyssey Micro Catheter | DQY | Substantially Equivalent | |
| K173052 | Heraeus TMW Guidewire | DQX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008988055 | 3008988055 | HERAEUS MEDICAL COMPONENTS, LLC | 5030 Centerville Road, Saint Paul, MN 55127 US | 2026 | |
| 3013666336 | 3013666336 | Heraeus Medical Components, SRL | Parque Industrial Zona Franca La Lima, Guadalupe Cartago 30106 CR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- KRACatheter, Continuous Flush
- DQYCatheter, Percutaneous
- DXFCatheter, Septostomy
- MMXDevice, Percutaneous Retrieval
- DREDilator, Vessel, For Percutaneous Catheterization
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- LWSImplantable Cardioverter Defibrillator (Non-Crt)
- DYBIntroducer, Catheter
- DTBPermanent Pacemaker Electrode
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief
- EZBStylet For Catheter, Gastro-Urology
- NTETemporary Carotid Catheter For Embolic Capture
- DQXWire, Guide, Catheter
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