Class I Cardiovascular device.
K821569 is an FDA 510(k) clearance for the LEATHER VALVULOTOME. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.
Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight framework. 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 | K821569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | May 27, 1982 |
| Decision Date | May 27, 1982 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | DWS Instruments, Surgical, Cardiovascular |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 870.4500 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.