510(k) K893704
K893704 is an FDA 510(k) premarket notification submitted by Polystan C/O Vitalcor, Inc. for the device "SAFE-1". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Polystan C/O Vitalcor, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1989
- Date Received
- May 18, 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