510(k) K840033 ยท FMI Needle, Hypodermic, Single Lumen
HYPODERMIC NEEDLES & STYLETS
| Applicant | Microvasive, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 5, 1984 |
| Received | Jan 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2004 | Boston Scientific Corporation Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasa Terminated |
KNW | None listed |
| Sep 14, 2004 | Boston Scientific Corporation Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 P Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.