AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
FDA 510(k) clearance K100646 · decided 2010-12-16
Clearance details
- K-number
- K100646
- Device name
- AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-05
- Decision date
- 2010-12-16
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- DTM
- Device class
- 2
- Regulation number
- 870.4260
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |