510(k) K193607 ยท DQY Catheter, Percutaneous
BOBBY Balloon Guide Catheter
| Applicant | MicroVention, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jul 21, 2020 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | MICROVENTION INC. BOBBY Balloon Guide Catheter
REF:
BOB-895-CN
BOB-895-EMEA
BOB-895-EMEA-AL
BOB-895-US
MV-BGA01095
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.