TSI Transseptal Introducer
FDA 510(k) clearance K181031 · decided 2018-10-26
Clearance details
- K-number
- K181031
- Device name
- TSI Transseptal Introducer
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-04-18
- Decision date
- 2018-10-26
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Morton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 recall (Z-0852-2023) | Biomerieux Inc | 2023-01-04 |