ShortCut
FDA 510(k) clearance DEN240017 · decided 2024-09-27
Clearance details
- K-number
- DEN240017
- Device name
- ShortCut
- Applicant
- Pi-Cardia, Ltd.
- Decision
- Unknown
- Date received
- 2024-04-17
- Decision date
- 2024-09-27
- Days to decision
- 163 days
- Clearance type
- Direct
- Product code
- SCZ
- Device class
- 2
- Regulation number
- 870.1254
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.