The following data is part of a De Novo classification by Anesthesia Safety Products, Llc with the FDA for Airpurge.
| DeNovo ID | DEN080009 |
| Device Name: | AIRPURGE |
| Classification | Intravascular Administration Set, Automated Air Removal System |
| Applicant | ANESTHESIA SAFETY PRODUCTS, LLC 155-m New Boston Street suite 127 Woburn, MA 01801 |
| Contact | Ihsan A Haddad |
| Product Code | OKL |
| CFR Regulation Number | 880.5445 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K080644 |
| Review Advisory Board | General Hospital |
| Classification Advisory | General Hospital |
| Type | Post-NSE |
| Date Received | 2008-10-29 |
| Decision Date | 2014-03-04 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863193000338 | DEN080009 | 000 |
| 00863193000321 | DEN080009 | 000 |