K011557 is an FDA 510(k) clearance for the PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS. This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on July 12, 2001, 52 days after receiving the submission on May 21, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K011557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2001 |
| Decision Date | July 12, 2001 |
| Days to Decision | 52 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF — Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |