Skip to product information
1 of 1

FDA 510(k) K043371, BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER, by Biomerix Corporation

FDA 510(k) K043371, BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER, by Biomerix Corporation

Regular price $449.22 USD
Regular price Sale price $449.22 USD
Sale Sold out

510(K) Number: K043371
Device Name: BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
Manufacturer: Biomerix Corporation
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 12/08/2004
Decision Date: 02/03/2005
Regulation Medical Specialty: Cardiovascular

Total pages: 594
Fully redacted pages: 507
Content pages: 87

View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome