The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Centri-safe(tm) Valve.
| Device ID | K921500 |
| 510k Number | K921500 |
| Device Name: | CENTRI-SAFE(TM) VALVE |
| Classification | Cpb Check Valve, Retrograde Flow, In-line |
| Applicant | CARDIO SYSTEMS, INC. 1027 CONSHOHOCKEN RD. P.O. BOX 606 Conshohocken, PA 19428 |
| Contact | David Wurzel |
| Correspondent | David Wurzel CARDIO SYSTEMS, INC. 1027 CONSHOHOCKEN RD. P.O. BOX 606 Conshohocken, PA 19428 |
| Product Code | MJJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-09-15 |