REUSABLE GUIDE
FDA 510(k) clearance K141334 · decided 2014-07-11
Clearance details
- K-number
- K141334
- Device name
- REUSABLE GUIDE
- Applicant
- Koelis
- Decision
- Substantially Equivalent
- Date received
- 2014-05-21
- Decision date
- 2014-07-11
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- La Tronche, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.