AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
FDA 510(k) clearance K093986 · decided 2010-01-22
Clearance details
- K-number
- K093986
- Device name
- AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-24
- Decision date
- 2010-01-22
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.