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 |