510(k) K192804 ยท QJP Catheter, Percutaneous, Neurovasculature
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
| Applicant | Medos International SARL, Le Locle, CH |
| Decision | Substantially Equivalent, Feb 27, 2020 |
| Received | Oct 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2024 | Medos International Sarl CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:
a) GS9080SD;
b) GS9090SD;
c) GS9095SD;
Vascular guide-catheter, single-use Open, Classified |
QJP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.