PROCATH PACING THRESHOLD CABLE— 510(k) K941058
Substantially EquivalentProfessional Catheter Corp.
FDA 510(k) clearance K941058 for PROCATH PACING THRESHOLD CABLE, Substantially Equivalent on 1994-07-11. Applicant: Professional Catheter Corp.. Device class: 2.
Clearance details
- Applicant
- Professional Catheter Corp.
- 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
- Berlin, NJ, US
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Adverse 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.