SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
FDA 510(k) clearance K241042 · decided 2024-05-17
Clearance details
- K-number
- K241042
- Device name
- SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-04-17
- Decision date
- 2024-05-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DRC
- Device class
- 2
- Regulation number
- 870.1390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Morton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.