INDEFLATOR
Catheter, Angioplasty, Peripheral, Transluminal
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Indeflator.
Pre-market Notification Details
| Device ID | K822245 |
| 510k Number | K822245 |
| Device Name: | INDEFLATOR |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-29 |
| Decision Date | 1982-08-31 |
Trademark Results [INDEFLATOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INDEFLATOR 73413681 1300405 Live/Registered |
Advanced Cardiovascular Systems, Inc. 1983-02-16 |
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