Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
FDA 510(k) clearance K203067 · decided 2021-11-08
Clearance details
- K-number
- K203067
- Device name
- Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
- Applicant
- Qura S.R.L
- Decision
- Substantially Equivalent
- Date received
- 2020-10-09
- Decision date
- 2021-11-08
- Days to decision
- 395 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.