K001390 is an FDA 510(k) clearance for the BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on July 21, 2000, 80 days after receiving the submission on May 2, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K001390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2000 |
| Decision Date | July 21, 2000 |
| Days to Decision | 80 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSA — Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |