Submission Details
| 510(k) Number | K061212 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2006 |
| Decision Date | July 10, 2006 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
BIOTRONIK ENDOCARDIAL PACING LEADS
Jul 2006
Decision
70d
Days
Class 3
Risk
About This 510(k) Submission
K061212 is an FDA 510(k) clearance for the BIOTRONIK ENDOCARDIAL PACING LEADS, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on July 10, 2006, 70 days after receiving the submission on May 1, 2006. 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
Similar Devices — DTB Permanent Pacemaker Electrode
All 486
K041809 · Oscor, Inc.
· Aug 2004
K040569 · Oscor, Inc.
· Apr 2004
K031274 · Medtronic Vascular
· May 2003
K031210 · Metronic, Inc.
· May 2003
K023205 · Biotronik, Inc.
· Apr 2003
K024053 · Oscor, Inc.
· Jan 2003
More from Biotronik, Inc.
View all
K250706
· LIT · Apr 2025
K242969
· LOX · Oct 2024
K240787
· DQY · Sep 2024
K241711
· LIT · Jul 2024
K230375
· MXD · May 2023