0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter— 510(k) K183043
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K183043 for 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter, Substantially Equivalent on 2019-04-17. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code NRY
view allMore clearances from Imperative Care, Inc.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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 →
Recalls naming K183043
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183043.
Data sourced from openFDA. This site is unofficial and independent of the FDA.