DIVER C.E. CATHETER
FDA 510(k) clearance K051917 · decided 2005-08-08
Clearance details
- K-number
- K051917
- Device name
- DIVER C.E. CATHETER
- Applicant
- Invatec Innovative Technologies, S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-15
- Decision date
- 2005-08-08
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- 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 |
|---|---|---|
| lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product i recall (Z-1517-2013) | Invatec Llc | 2013-06-07 |