The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Indeflator 20/30 Inflation Device And 20/30 Priority Pack (with The .096 Or .115 Rotating Hemostatic Valve).
| Device ID | K961471 |
| 510k Number | K961471 |
| Device Name: | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) |
| Classification | Syringe, Balloon Inflation |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1996-05-08 |
| Summary: | summary |