SpeediCath Compact Eve
Catheter, Urethral
COLOPLAST A/S
The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Speedicath Compact Eve.
Pre-market Notification Details
| Device ID | K150935 |
| 510k Number | K150935 |
| Device Name: | SpeediCath Compact Eve |
| Classification | Catheter, Urethral |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Meg Daniel |
| Correspondent | Meg Daniel COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-07 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
Trademark Results [SpeediCath Compact Eve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDICATH COMPACT EVE 90504060 not registered Live/Pending |
Coloplast A/S 2021-02-02 |
 SPEEDICATH COMPACT EVE 79139645 4578151 Live/Registered |
Coloplast A/S 2013-10-24 |
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