Submission Details
| 510(k) Number | K003454 FDA.gov |
| FDA Decision | Cleared ST |
| Date Received | November 07, 2000 |
| Decision Date | January 18, 2001 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Special
A1-CS-SB Y-ADAPTER, MODEL 124 871
Jan 2001
Decision
72d
Days
Class 2
Risk
About This 510(k) Submission
K003454 is an FDA 510(k) clearance for the A1-CS-SB Y-ADAPTER, MODEL 124 871, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on January 18, 2001, 72 days after receiving the submission on November 7, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.
Device Classification
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3620 |
Manufacturer
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