The following data is part of a premarket notification filed by Adapta Medical, Inc with the FDA for Colorado Catheter Sterilesure - New Name Perfic Cath.
| Device ID | K103043 |
| 510k Number | K103043 |
| Device Name: | COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH |
| Classification | Catheter, Straight |
| Applicant | ADAPTA MEDICAL, INC 4250 GROVE STREET Denver, CO 80211 |
| Contact | Neil Burris |
| Correspondent | Neil Burris ADAPTA MEDICAL, INC 4250 GROVE STREET Denver, CO 80211 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2011-01-07 |
| Summary: | summary |