NAUTILUS DELTA
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
ROMEDEX INTERNATIONAL SRL
The following data is part of a premarket notification filed by Romedex International Srl with the FDA for Nautilus Delta.
Pre-market Notification Details
| Device ID | K141634 |
| 510k Number | K141634 |
| Device Name: | NAUTILUS DELTA |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ROMEDEX INTERNATIONAL SRL 625 CLAYTON STR San Francisco, CA 94117 |
| Contact | Sorin Grunwald |
| Correspondent | Sorin Grunwald ROMEDEX INTERNATIONAL SRL 625 CLAYTON STR San Francisco, CA 94117 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-18 |
| Decision Date | 2015-01-27 |
| Summary: | summary |
Trademark Results [NAUTILUS DELTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAUTILUS DELTA 87632228 5468411 Live/Registered |
Bard Access Systems, Inc. 2017-10-03 |
 NAUTILUS DELTA 86307643 4684334 Live/Registered |
BARD ACCESS SYSTEMS, INC. 2014-06-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.