510(k) K043500 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
| Applicant | Innospine, Inc., Los Altos Hills CA, US |
| Decision | Substantially Equivalent, Apr 15, 2005 |
| Received | Dec 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2008 | Kyphon Inc Functional Anaesthetic Discography (F.A.D.) Catheter
System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089 Terminated |
BSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.