510(k) K212675
K212675 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Aspira Peritoneal Drainage System". The FDA issued a decision of Substantially Equivalent (kit) on December 14, 2021. The device falls under product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 14, 2021
- Date Received
- August 24, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.