Guide Sheath
Introducer, Catheter
Surmodics, Inc.
The following data is part of a premarket notification filed by Surmodics, Inc. with the FDA for Guide Sheath.
Pre-market Notification Details
| Device ID | K190644 |
| 510k Number | K190644 |
| Device Name: | Guide Sheath |
| Classification | Introducer, Catheter |
| Applicant | Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 |
| Contact | Peggy Ju |
| Correspondent | Peggy Ju Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2019-04-18 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391525785189 | K190644 | 000 |
| 05391525785172 | K190644 | 000 |
| 05391525785165 | K190644 | 000 |
| 05391525785158 | K190644 | 000 |
| 05391525785141 | K190644 | 000 |
| 05391525785134 | K190644 | 000 |
| 05391525785127 | K190644 | 000 |
| 05391525785110 | K190644 | 000 |
Trademark Results [Guide Sheath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDE SHEATH 87492983 not registered Dead/Abandoned |
Olympus Corporation 2017-06-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.