510(k) K082403
K082403 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT". The FDA issued a decision of Substantially Equivalent on May 15, 2009. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2009
- Date Received
- August 21, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type