510(k) K021228 ยท DQX Wire, Guide, Catheter
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
| Applicant | Guidant Corp., Temecula CA, US |
| Decision | Substantially Equivalent, May 15, 2002 |
| Received | Apr 18, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.