# Heraeus Medical Components, LLC

- Location (FDA's records): Plymouth, MN
- FDA decisions: 4 (2017–2019): 4 510(k) clearances
- Product codes: DQX (2), KRA (1), DQY (1)
- 510(k) review time since 2016: median 196 days, against 123 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Vascular: 2 (https://510kreport.com/company/abbott-vascular)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Recent decisions
- K191305: Hereaeus Poseidon Microcatheter (Dec 19, 2019)
- K191502: Heraeus Peripheral Guidewire (Nov 26, 2019)
- K170664: Odyssey Micro Catheter (Nov 9, 2017)
- K173052: Heraeus TMW Guidewire (Oct 20, 2017)

Source page: https://510kreport.com/company/heraeus-medical-components