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 | K181463 |
| 510k Number | K181463 |
| 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 | 2018-06-04 |
| Decision Date | 2018-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046955685899 | K181463 | 000 |
| 04046955669134 | K181463 | 000 |
| 04046955669110 | K181463 | 000 |
| 04046955669097 | K181463 | 000 |
| 04046955669073 | K181463 | 000 |
| 04046955669059 | K181463 | 000 |
| 04046955669035 | K181463 | 000 |
| 04046955669011 | K181463 | 000 |
| 04046955668991 | K181463 | 000 |
| 04046955668977 | K181463 | 000 |
| 04046955668953 | K181463 | 000 |
| 04046955668939 | K181463 | 000 |
| 04046955668915 | K181463 | 000 |
| 04046955668892 | K181463 | 000 |
| 04046955668878 | K181463 | 000 |
| 04046955668854 | K181463 | 000 |
| 04046955668830 | K181463 | 000 |
| 04046955669158 | K181463 | 000 |
| 04046955669172 | K181463 | 000 |
| 04046955669196 | K181463 | 000 |
| 04046955685097 | K181463 | 000 |
| 04046955685073 | K181463 | 000 |
| 04046955685059 | K181463 | 000 |
| 04046955685035 | K181463 | 000 |
| 04046955685011 | K181463 | 000 |
| 04046955684892 | K181463 | 000 |
| 04046955684878 | K181463 | 000 |
| 04046955684854 | K181463 | 000 |
| 04046955669356 | K181463 | 000 |
| 04046955669332 | K181463 | 000 |
| 04046955669318 | K181463 | 000 |
| 04046955669295 | K181463 | 000 |
| 04046955669271 | K181463 | 000 |
| 04046955669257 | K181463 | 000 |
| 04046955669233 | K181463 | 000 |
| 04046955669219 | K181463 | 000 |
| 04046955668816 | K181463 | 000 |