The following data is part of a premarket notification filed by Steris Corporation with the FDA for Trufreeze Console, Pn Cc301; Aire Pv Passive Venting Catheter, Pn Co840703; 16 Fr Cdt 5 Pack, Pn 2000181; 20fr Cdt 5 Pack, Pn Acccc3cdt05; Active Venting Spray Kit, 20 Fr Cdt, Pn 2000177; Active Venting Spray Kit 16 Fr Cdt, Pn 20000516; Rapid Av Cath.
| Device ID | K223369 |
| 510k Number | K223369 |
| Device Name: | TruFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Cath |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-11-04 |
| Decision Date | 2022-12-02 |