K000570 is an FDA 510(k) clearance for the BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 13, 2000, 51 days after receiving the submission on February 22, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K000570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2000 |
| Decision Date | April 13, 2000 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |