The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Airway Balloon Catheter Inflation Device.
| Device ID | K090660 |
| 510k Number | K090660 |
| Device Name: | AIRWAY BALLOON CATHETER INFLATION DEVICE |
| Classification | Bronchoscope Accessory |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Keri Yen |
| Correspondent | Keri Yen ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-12 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031242682 | K090660 | 000 |
| 20705031063317 | K090660 | 000 |
| 20705031131993 | K090660 | 000 |
| 20705031132068 | K090660 | 000 |
| 20705031147734 | K090660 | 000 |
| 20705031206059 | K090660 | 000 |
| 20705031063089 | K090660 | 000 |
| 20705031063126 | K090660 | 000 |
| 20705031063157 | K090660 | 000 |
| 20705031063171 | K090660 | 000 |
| 20705031147703 | K090660 | 000 |
| 20705031063294 | K090660 | 000 |