510(k) K894630
K894630 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on October 20, 1989. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Shiley, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1989
- Date Received
- July 24, 1989
- 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