Stiletto Extended Dwell Catheter
FDA 510(k) clearance K210047 · decided 2021-08-27
Clearance details
- K-number
- K210047
- Device name
- Stiletto Extended Dwell Catheter
- Applicant
- Piper Access, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-01-08
- Decision date
- 2021-08-27
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- PND
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.