FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
FDA 510(k) clearance K100799 · decided 2011-02-25
Clearance details
- K-number
- K100799
- Device name
- FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
- Applicant
- Contract Medical Intl. GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-03-22
- Decision date
- 2011-02-25
- Days to decision
- 340 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dresden, Sachsen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.