UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493— 510(k) K922269
Substantially EquivalentThe Heart Valve Div. Medtronic Cardiovascular Surg
FDA 510(k) clearance K922269 for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493, Substantially Equivalent on 1992-11-23. Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg. Device class: 2.
Clearance details
- Applicant
- The Heart Valve Div. Medtronic Cardiovascular Surg
- 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
- Minneapolis, MN, US
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- K241199 — Rotatable Connector (5944RL)
More clearances from The Heart Valve Div. Medtronic Cardiovascular Surg
view allAdverse 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.