The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Armanda 14 Pta Catheter.
| Device ID | K102705 |
| 510k Number | K102705 |
| Device Name: | ARMANDA 14 PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ABBOTT VASCULAR INC. 3200 LAKESIDE DRIVE Santa Clara, CA 92054 |
| Contact | Laarni Ricafort |
| Correspondent | Laarni Ricafort ABBOTT VASCULAR INC. 3200 LAKESIDE DRIVE Santa Clara, CA 92054 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2010-12-07 |
| Summary: | summary |