Company ยท US
Bolton Medical Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2002. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
5recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2026 | Bolton Medical Inc. RelayPro Thoracic Stent-Graft System (various sizes)
Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34- Open, Classified |
MIH | None listed |
| Mar 27, 2024 | Bolton Medical Inc. RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile:
(a) Part number 28-M4-34-100-34U;
(b) Part number 28-M4-30-095-30U;
(c) Completed |
MIH | None listed |
| Jun 6, 2023 | Bolton Medical Inc. The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Ili Open, Classified |
MIH | None listed |
| Jan 19, 2023 | Bolton Medical Inc. RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX Open, Classified |
MIH | None listed |
| Jan 19, 2023 | Bolton Medical Inc. RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX Open, Classified |
MIH | None listed |