Submission Details
| 510(k) Number | K880738 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 1988 |
| Decision Date | November 17, 1988 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
MODEL 2331T PATIENT PROGRAMMER
Nov 1988
Decision
267d
Days
Class 3
Risk
About This 510(k) Submission
K880738 is an FDA 510(k) clearance for the MODEL 2331T PATIENT PROGRAMMER, a Programmer, Pacemaker (Class III — Premarket Approval, product code KRG), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 17, 1988, 267 days after receiving the submission on February 24, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3700.
Device Classification
| Product Code | KRG — Programmer, Pacemaker |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 870.3700 |
Manufacturer
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