Sphere-9Dx Diagnostic Catheter (AFR-00009)— 510(k) K233433
Substantially EquivalentMedtronic
FDA 510(k) clearance K233433 for Sphere-9Dx Diagnostic Catheter (AFR-00009), Substantially Equivalent on 2024-08-07. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
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- K223666 — Ablacath Mapping Catheter
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- K223494 — CD Horizon Spinal System
- K223178 — SelectSite C304 Deflectable Catheter System, C315 Delivery System
Adverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
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.