The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Presto Inflation Device.
| Device ID | K143522 |
| 510k Number | K143522 |
| Device Name: | Presto Inflation Device |
| Classification | Syringe, Balloon Inflation |
| Applicant | C.R. BARD, INC. 1625 W.3RD STREET Tempe, AZ 85281 |
| Contact | Timothy Wade |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-01-12 |
| Summary: | summary |