DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS
FDA 510(k) clearance K954317 · decided 1995-11-28
Clearance details
- K-number
- K954317
- Device name
- DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-15
- Decision date
- 1995-11-28
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The recall (Z-0108-2015) | St Jude Medical | 2014-10-22 |