# Medamicus, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 20 (1989–2004): 20 510(k) clearances
- Product codes: DYB (14), FEN (3), GZB (2), DXO (1)
- Predicates its devices cite: 15 (11 its own); citations of its devices by later devices: 27 (11 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Neuromed, Inc.: 1 (https://510kreport.com/company/neuromed)
- North American Sterilization & Packaging Co.: 1 (https://510kreport.com/company/north-american-sterilization-packaging)

## Firms that cite its devices most
- Injectimed, Inc.: 3 (https://510kreport.com/company/injectimed)
- Enpath Medical, Inc.: 3 (https://510kreport.com/company/enpath-medical)
- Care Fusion: 2 (https://510kreport.com/company/care-fusion)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Medcomp: 2 (https://510kreport.com/company/medcomp)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Its most-cited devices
- K040150: Modification to Medamicus Flowguard Peelable Introducer (2004), cited by 5
- K011085: Guidewire Introducer Safety Needle (2001), cited by 4
- K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set (1999), cited by 4
- K000824: Percutaneous Introducer, Model 10383-XXX (2000), cited by 2
- K965167: Percutaneous Venous Introducer 10264 (1997), cited by 2
- K020563: Medamicus Axia RSN (2002), cited by 2

## Recent decisions
- K040150: Modification to Medamicus Flowguard Peelable Introducer (Feb 18, 2004)
- K030905: Medamicus Flowguard Peelable Introducer (Apr 9, 2003)
- K022689: Modification to Medamicus Axia RSN (Aug 23, 2002)
- K021004: Valved Peelable Introducer (Jun 6, 2002)
- K020563: Medamicus Axia RSN (May 21, 2002)
- K013120: Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 (Jan 24, 2002)
- K011085: Guidewire Introducer Safety Needle (Jul 9, 2001)
- K000824: Percutaneous Introducer, Model 10383-XXX (Apr 13, 2000)

Source page: https://510kreport.com/company/medamicus