The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Ultraverse 014 And 018 Pta Balloon Dilatation Catheters.
| Device ID | K192318 |
| 510k Number | K192318 |
| Device Name: | Ultraverse 014 And 018 PTA Balloon Dilatation Catheters |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Bard Peripheral Vascular, Inc. 1625 West 3rd St Tempe, AZ 85281 |
| Contact | Andrew Quach |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2019-10-03 |