# Imds Operations B.V.

- Location (FDA's records): Roden, NL
- FDA decisions: 8 (2012–2025): 8 510(k) clearances
- Product codes: DQY (8)
- 510(k) review time since 2016: median 178 days, against 114 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 3 (3 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
- Vascular Solutions, Inc.: 3 (https://510kreport.com/company/vascular-solutions)
- Creganna Medical Aslo Business AS Cregganna Tactx Medical: 1 (https://510kreport.com/company/creganna-medical-aslo-business-as-cregganna-tactx-medical)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)

## Its most-cited devices
- K210110: Guidion (2021), cited by 1
- K223728: Micro Rx (2023), cited by 1
- K200324: NHancer Rx (2020), cited by 1

## Recent decisions
- K242337: FlowGuide (FG60F); GuidionShort (GS60F) (Apr 17, 2025)
- K241611: ShapeIT (SI014135) (Sep 3, 2024)
- K223728: Micro Rx (Jul 13, 2023)
- K210431: ReCross (Jul 15, 2021)
- K210110: Guidion (Mar 31, 2021)
- K200324: NHancer Rx (Aug 6, 2020)
- K191229: TrapIt (Jan 21, 2020)
- K121077: Nhancer (Dec 21, 2012)

Source page: https://510kreport.com/company/imds-operations