Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
FDA 510(k) clearance K153533 · decided 2016-07-05
Clearance details
- K-number
- K153533
- Device name
- Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
- Applicant
- Galt Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-09
- Decision date
- 2016-07-05
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Garland, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 recall (Z-1968-2023) | Galt Medical Corporation | 2023-06-15 |
| Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, recall (Z-1969-2023) | Galt Medical Corporation | 2023-06-15 |