Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Gastroenterology, Urology · 21 CFR 876.5550
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
15 firms currently registered for this product code
Boston Scientific Corporation
Maple Grove, MN, US
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
QUINCY, MA, US
Microvention, Inc.
Aliso Viejo, CA, US
Boston Scientific Limited
CORK Munster, IE
Merit Medical Uk Limited
Earley Reading, GB
Boston Scientific Corporation
Saint Paul, MN, US
Varian Medical Systems, Inc
Austin, TX, US
Biosphere Medical, S.a.
Roissy Val-d'Oise, FR
Merit Medical Canada Ltd.
Markham Ontario, CA
Boston Scientific International Bv, European Dist. Ctr.
KERKRADE Limburg, NL
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
510(k) clearances
4 clearances for this product code
- Biocompatibles UK Ltd (Part of Boston Scientific CorporationApr 20, 2021
K203276 · Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
- MicroVention, Inc.Jan 22, 2020
K192684 · HydroPearl Microspheres
- Boston ScientificApr 19, 2018
K180102 · Embozene Color-Advanced Microspheres
- Biosphere Medical, S.A.Jun 21, 2017
DEN160040 · Embosphere Microspheres