Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm— 510(k) K231279
Substantially EquivalentAblative Solutions, Inc.
FDA 510(k) clearance K231279 for Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm, Substantially Equivalent on 2023-07-05. Applicant: Ablative Solutions, Inc..
Clearance details
- Applicant
- Ablative Solutions, Inc.
- Product code
- Code KRA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wakefield, MA, US
Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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.