K050684 is an FDA 510(k) clearance for the ATLANTIS PV. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on May 20, 2005, 64 days after receiving the submission on March 17, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K050684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2005 |
| Decision Date | May 20, 2005 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |