510(k) K943803
K943803 is an FDA 510(k) premarket notification submitted by Janus Biomedical, Inc. for the device "JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Janus Biomedical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1996
- Date Received
- August 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type