VIA MICROCATHETER, VIA PLUS MICROCATHETER
FDA 510(k) clearance K132652 · decided 2013-12-20
Clearance details
- K-number
- K132652
- Device name
- VIA MICROCATHETER, VIA PLUS MICROCATHETER
- Applicant
- Sequent Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-26
- Decision date
- 2013-12-20
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended recall (Z-0114-2017) | Sequent Medical Inc | 2016-10-27 |