0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
FDA 510(k) clearance K183043 · decided 2019-04-17
Clearance details
- K-number
- K183043
- Device name
- 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
- Applicant
- Imperative Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-02
- Decision date
- 2019-04-17
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- NRY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 recall (Z-2577-2021) | IMPERATIVE CARE INC | 2021-09-29 |