AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
FDA 510(k) clearance K151667 · decided 2015-11-13
Clearance details
- K-number
- K151667
- Device name
- AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2015-06-19
- Decision date
- 2015-11-13
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior( recall (Z-0275-2018) | Stryker Neurovascular | 2017-12-05 |
| Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM recall (Z-0276-2018) | Stryker Neurovascular | 2017-12-05 |
| Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior recall (Z-0277-2018) | Stryker Neurovascular | 2017-12-05 |