510(k) K961137
K961137 is an FDA 510(k) premarket notification submitted by Apheresis Technologies, Inc. for the device "ATI PLASMA PUMP (PP-04)". The FDA issued a decision of Substantially Equivalent on June 14, 1996. The device falls under product code FIR (Pump, Blood, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Apheresis Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1996
- Date Received
- March 21, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Extra-Luminal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type