The following data is part of a premarket notification filed by Adapta Medical, Inc with the FDA for Perfic Cath Gel S, Perfic Cath Gel C, Perfic Cath Hydro S, Perfic Cath Hydro C.
| Device ID | K161445 |
| 510k Number | K161445 |
| Device Name: | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C |
| Classification | Catheter, Straight |
| Applicant | ADAPTA MEDICAL, INC 142 TALAMINE COURT Colorado Springs, CO 80907 |
| Contact | Adrian Elfe |
| Correspondent | Neil Burris NEIL BURRIS & ASSOCIATES 4250 GROVE STREET Denver, CO 80211 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-08-16 |
| Summary: | summary |