CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
FDA 510(k) clearance K192804 · decided 2020-02-27
Clearance details
- K-number
- K192804
- Device name
- CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2019-10-01
- Decision date
- 2020-02-27
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- QJP
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; V recall (Z-1284-2024) | Medos International Sarl | 2024-03-13 |