510(k) K133694
K133694 is an FDA 510(k) premarket notification submitted by Paragonix Technologies, Inc. for the device "SHERPA PAK TRANSPORTER". The FDA issued a decision of Substantially Equivalent on May 23, 2014. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Paragonix Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2014
- Date Received
- December 3, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Perfusion, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type