SubQKath Catheter and Needle Set
FDA 510(k) clearance K193664 · decided 2020-09-09
Clearance details
- K-number
- K193664
- Device name
- SubQKath Catheter and Needle Set
- Applicant
- Hk Surgical
- Decision
- Substantially Equivalent
- Date received
- 2019-12-31
- Decision date
- 2020-09-09
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.