Fortress Introducer Sheath SYstem
FDA 510(k) clearance K153197 · decided 2016-01-11
Clearance details
- K-number
- K153197
- Device name
- Fortress Introducer Sheath SYstem
- Applicant
- Contract Medical International, GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-11-04
- Decision date
- 2016-01-11
- Days to decision
- 68 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dresden, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath Sys recall (Z-2532-2025) | Contract Medical International GmbH | 2025-09-05 |