The following data is part of a premarket notification filed by Contract Medical Intl. Gmbh with the FDA for Fortress Introducer Sheath System Model 358813, 358814, 358815.
| Device ID | K100799 |
| 510k Number | K100799 |
| Device Name: | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 |
| Classification | Introducer, Catheter |
| Applicant | CONTRACT MEDICAL INTL. GMBH ZUR WETTERWARTE 50 Dresden, Sachsen, DE 01109 |
| Contact | Jan Kloboucnik |
| Correspondent | Jan Kloboucnik CONTRACT MEDICAL INTL. GMBH ZUR WETTERWARTE 50 Dresden, Sachsen, DE 01109 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2011-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14251244500563 | K100799 | 000 |
| 14251244500037 | K100799 | 000 |
| 04251244500023 | K100799 | 000 |
| 14251244500013 | K100799 | 000 |