K843001 is an FDA 510(k) clearance for the COOK PACEMAKER CORP. 116 BIOPOLAR CARDI.
Submitted by Cook Pacemaker Corp. (Walker, US). The FDA issued a Cleared decision on July 30, 1984.
This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K843001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | July 30, 1984 |
| Decision Date | July 30, 1984 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | - |
| Device Class | - |
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.