The following data is part of a premarket notification filed by Romedex International Srl with the FDA for Evguide Tip Location System.
| Device ID | K093775 |
| 510k Number | K093775 |
| Device Name: | EVGUIDE TIP LOCATION SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ROMEDEX INTERNATIONAL SRL 175 COLORADO AVENUE Palo Alto, CA 94303 |
| Contact | Sorin Grunwald |
| Correspondent | Sorin Grunwald ROMEDEX INTERNATIONAL SRL 175 COLORADO AVENUE Palo Alto, CA 94303 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-08 |
| Decision Date | 2010-07-15 |
| Summary: | summary |