091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
FDA 510(k) clearance K172468 · decided 2017-12-06
Clearance details
- K-number
- K172468
- Device name
- 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
- Applicant
- Inneuroco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-15
- Decision date
- 2017-12-06
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunrise, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer recall (Z-1708-2019) | Stryker Neurovascular | 2019-06-02 |