TME Temporary Myocardial Electrode— 510(k) K232261
Substantially EquivalentOsypka AG
FDA 510(k) clearance K232261 for TME Temporary Myocardial Electrode, Substantially Equivalent on 2024-04-26. Applicant: Osypka AG. Device class: 2.
Clearance details
- Applicant
- Osypka AG
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rheinfelden, DE
Recent devices under product code LDF
view all- K252042 — Sync AV II Temporary Pacing Catheter
- K242863 — Bioptimal Bipolar Pacing Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
- K241199 — Rotatable Connector (5944RL)
Adverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.