The following data is part of a premarket notification filed by Infinity Angioplasty Balloon Company, Llc with the FDA for Infinity Angioplasty Balloon Catheter.
| Device ID | K192399 |
| 510k Number | K192399 |
| Device Name: | Infinity Angioplasty Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Infinity Angioplasty Balloon Company, LLC 6865 N. Reynolds Rd Suite 200 Toledo, OH 43615 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer Infinity Angioplasty Balloon Company, LLC 6865 N. Reynolds Rd Suite 200 Toledo, OH 43615 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-05-20 |