SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.
FDA 510(k) clearance K931584 · decided 1993-07-01
Clearance details
- K-number
- K931584
- Device name
- SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.
- Applicant
- Scimed
- Decision
- Substantially Equivalent
- Date received
- 1993-03-31
- Decision date
- 1993-07-01
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, recall (Z-0122-2008) | Boston Scientific Target | 2007-12-05 |