The following data is part of a premarket notification filed by Contract Medical International Gmbh with the FDA for Durasheath Introducer Sheath System.
| Device ID | K142357 |
| 510k Number | K142357 |
| Device Name: | DuraSheath Introducer Sheath System |
| Classification | Introducer, Catheter |
| Applicant | CONTRACT MEDICAL INTERNATIONAL GMBH LAUENSTEINER STR, 37 Dresden, DE 01277 |
| Contact | Jan Kloboucnik |
| Correspondent | Jan Kloboucnik CONTRACT MEDICAL INTERNATIONAL GMBH LAUENSTEINER STR, 37 Dresden, DE 01277 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2015-06-25 |
| Summary: | summary |