# Bolton Medical, Inc.

- Location (FDA's records): Sunrise
- FDA decisions: 4 (2002–2021): 1 510(k) clearance and 3 original PMA approvals
- Product codes: MIH (3), LIT (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Scimed, Inc.: 1 (https://510kreport.com/company/boston-scientific-scimed)
- NuMED, Inc.: 1 (https://510kreport.com/company/numed)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)
- Mallinckroot, Inc.: 1 (https://510kreport.com/company/mallinckroot)
- Vas-Cath, Inc.: 1 (https://510kreport.com/company/vas-cath)

## Recent decisions
- P200045: RelayPro Thoracic Stent-Graft System (Aug 5, 2021)
- P190015: TREO® Abdominal Stent-Graft System (May 4, 2020)
- P110038: Relay Thoracic Stent-Graft with Plus Delivery System (Sep 21, 2012)
- K021996: Bolton Pta Catheter (Aug 23, 2002)

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