The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Rotating Hemo Valve - Dual Access Type.
| Device ID | K861847 |
| 510k Number | K861847 |
| Device Name: | ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-13 |
| Decision Date | 1986-06-16 |