The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Armada 18 Pta Catheter.
| Device ID | K151317 |
| 510k Number | K151317 |
| Device Name: | Armada 18 PTA Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ABBOTT VASCULAR 3200 LAKESIDE DR Santa Clara, CA 95054 |
| Contact | Shu Chi Hsu |
| Correspondent | Shu Chi Hsu ABBOTT VASCULAR 3200 LAKESIDE DR Santa Clara, CA 95054 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-07-06 |
| Summary: | summary |