Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter— 510(k) K241388
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K241388 for Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter, Substantially Equivalent on 2025-01-02. Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.
Clearance details
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Product code
- Code QJP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.