DiscCath Needle Set
FDA 510(k) clearance K212328 · decided 2021-09-26
Clearance details
- K-number
- K212328
- Device name
- DiscCath Needle Set
- Applicant
- Disccath, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-07-27
- Decision date
- 2021-09-26
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.