Signal Catheter
Catheter, Retention Type, Balloon
Safe Medical Design
The following data is part of a premarket notification filed by Safe Medical Design with the FDA for Signal Catheter.
Pre-market Notification Details
| Device ID | K182635 |
| 510k Number | K182635 |
| Device Name: | Signal Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Safe Medical Design 2722 Fulton Street San Francisco, CA 94118 |
| Contact | Raymond "buzz" Bonneau |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
Trademark Results [Signal Catheter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGNAL CATHETER 87590378 5723961 Live/Registered |
SAFE MEDICAL DESIGN INC. 2017-08-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.