510(k) K150893 ยท BSK Cuff, Tracheal Tube, Inflatable
IntelliCuff
| Applicant | Hamilton Medical AG, Bonaduz, CH |
| Decision | Substantially Equivalent, Jan 29, 2016 |
| Received | Apr 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150893
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Hamilton Medical AG IntelliCuff, Portable automatic cuff pressure controller
REF: 951001 Open, Classified |
BSK | None listed |
| Jun 20, 2017 | Hamilton Medical, Inc. Intellicuff Standalone (PN 951001)
Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used Open, Classified |
BSK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.