PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A— 510(k) K093858
Substantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisi
FDA 510(k) clearance K093858 for PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A, Substantially Equivalent on 2010-04-02. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi. Device class: 2.
Clearance details
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sylmar, CA, US
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More clearances from St. Jude Medical, Cardiac Rhythm Management Divisi
view allAdverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.