The following data is part of a premarket notification filed by Cure Medical Llc. with the FDA for Cure Catheter.
| Device ID | K110653 |
| 510k Number | K110653 |
| Device Name: | CURE CATHETER |
| Classification | Catheter, Straight |
| Applicant | CURE MEDICAL LLC. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
| Contact | Robyn Scopis |
| Correspondent | Robyn Scopis CURE MEDICAL LLC. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815947020288 | K110653 | 000 |
| 20815947020271 | K110653 | 000 |
| 20815947020264 | K110653 | 000 |
| 20815947020257 | K110653 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CURE CATHETER 86125386 4591923 Live/Registered |
Cure Medical, LLC 2013-11-21 |
![]() CURE CATHETER 78348044 3110064 Live/Registered |
CURE MEDICAL LLC 2004-01-06 |