K031164 is an FDA 510(k) clearance for the PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV. This device is classified as a Pacemaker Lead Adaptor (Class II - Special Controls, product code DTD).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 19, 2003, 66 days after receiving the submission on April 14, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K031164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | April 14, 2003 |
| Decision Date | June 19, 2003 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DTD - Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |