The following data is part of a premarket notification filed by Contract Medical International Gmbh with the FDA for Fortress Introducer Sheath System.
| Device ID | K153197 |
| 510k Number | K153197 |
| Device Name: | Fortress Introducer Sheath SYstem |
| Classification | Introducer, Catheter |
| Applicant | CONTRACT MEDICAL INTERNATIONAL GMBH LAUENSTEINER STRASSE 37 Dresden, DE 01277 |
| Contact | Jan Kloboucnik |
| Correspondent | Jan Kloboucnik CONTRACT MEDICAL INTERNATIONAL GMBH LAUENSTEINER STRASSE 37 Dresden, DE 01277 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-04 |
| Decision Date | 2016-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14251244500600 | K153197 | 000 |
| 14251244503663 | K153197 | 000 |
| 14251244503670 | K153197 | 000 |
| 14251244503687 | K153197 | 000 |
| 14251244503694 | K153197 | 000 |
| 14251244503700 | K153197 | 000 |
| 14251244503717 | K153197 | 000 |
| 14251244503724 | K153197 | 000 |
| 14251244503731 | K153197 | 000 |
| 14251244503748 | K153197 | 000 |
| 14251244500044 | K153197 | 000 |
| 14251244500051 | K153197 | 000 |
| 14251244500068 | K153197 | 000 |
| 14251244500082 | K153197 | 000 |
| 14251244500099 | K153197 | 000 |
| 14251244500570 | K153197 | 000 |
| 14251244500587 | K153197 | 000 |
| 14251244500594 | K153197 | 000 |
| 14251244503656 | K153197 | 000 |