The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Indeflator Plus 30/plus 30 Priority Pack9with The.096 Or.115 Rotating Hemostatic Valve).
| Device ID | K962495 |
| 510k Number | K962495 |
| Device Name: | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH 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 | Margaret Anderson |
| Correspondent | Margaret Anderson ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95052 -8167 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-26 |
| Decision Date | 1996-09-12 |
| Summary: | summary |