The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Atlas Gold Pta Dilatation Catheter.
| Device ID | K181323 |
| 510k Number | K181323 |
| Device Name: | Atlas Gold PTA Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | C. R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Contact | Aaron Conovaloff |
| Correspondent | Aaron Conovaloff C. R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-18 |
| Decision Date | 2018-08-03 |
| Summary: | summary |