The following data is part of a premarket notification filed by Compactcath Inc. with the FDA for Compactcath Intermittent Urinary Catheter.
| Device ID | K160858 |
| 510k Number | K160858 |
| Device Name: | CompactCath Intermittent Urinary Catheter |
| Classification | Catheter, Straight |
| Applicant | COMPACTCATH INC. 887 FEDERATION WAY Palo Alto, CA 94303 |
| Contact | Naama Stauber Breckler |
| Correspondent | Naama Stauber Breckler COMPACTCATH INC. 887 FEDERATION WAY Palo Alto, CA 94303 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-04-26 |
| Summary: | summary |