Submission Details
| 510(k) Number | K031274 FDA.gov |
| FDA Decision | Cleared ST |
| Date Received | April 22, 2003 |
| Decision Date | May 22, 2003 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Special
MODEL 5071 MYOCARDIAL PACING LEAD
May 2003
Decision
30d
Days
Class 3
Risk
About This 510(k) Submission
K031274 is an FDA 510(k) clearance for the MODEL 5071 MYOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 22, 2003, 30 days after receiving the submission on April 22, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.
Device Classification
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |
Manufacturer
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