510(k) K770977 ยท DQX Wire, Guide, Catheter
CARDIOVASCULAR SPRING GUIDES
| Applicant | Lake Region Mfg., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 14, 1977 |
| Received | May 31, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | Bard Peripheral Vascular Inc Guidewire 70cm x 1mm (0.038 ) REF 5583705
These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen
Hemodialysis Catheters. Please refer to the applicable catheter Instructions f Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.