Data / Medical devices / United States / Heraeus Medical Components, LLC
Heraeus Medical Components, LLC: FDA-registered device maker in Saint Paul, MN, United States, 8 510(k) clearances
Heraeus Medical Components, LLC is registered with the FDA (registration 3008988055) in Saint Paul, MN, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008988055
- Address
- 5030 Centerville Road, Saint Paul, MN, United States, 55127
- Owner or operator
- Heraeus Medical Components, LLC (9045241)
- Roles
- Complaint file establishment, Contract manufacturer, Specification developer
- First device listed
- October 16, 2007
- Registered through
- 2026
- Brand names listed
- Spring Coil Guidewire, Vascupuncture Guidewires
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Percutaneous Retrieval | MMX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Contract manufacturer | accessdata.fda.gov |
| Permanent Pacemaker Electrode | DTB | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | 3 | Contract manufacturer | accessdata.fda.gov |
| Stylet For Catheter, Gastro-Urology | EZB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2015 | K152560 | Bard Snare Retrieval Kit | MMX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| March 16, 2015 | K150225 | NovaGold High Performance Guidewire | OCY | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| February 20, 2015 | K143135 | Spring Coil Guidewire | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| February 15, 2007 | K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| March 1, 2005 | K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| April 19, 2004 | K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| September 30, 2003 | K031652 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| February 5, 2002 | K012861 | VASCUPUNCTURE ACCESS WIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
- All makers of Stylet For Catheter, Gastro-Urology
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
- All makers of Wire, Guide, Catheter
- All makers of Endoscopic Guidewire, Gastroenterology-Urology
- All makers of Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Updated October 23, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.