510(k) K153197 ยท DYB Introducer, Catheter
Fortress Introducer Sheath SYstem
| Applicant | Contract Medical International, GmbH, Dresden, DE |
| Decision | Substantially Equivalent, Jan 11, 2016 |
| Received | Nov 4, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Contract Medical International GmbH Brand Name: Fortress Introducer Sheath System
Product Name: Fortress Introducer Sheath System
Model/Catalog Number: 386594
Product Description: Fortress Introducer Sheath System, 6F Straight 45cm: Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.