510(k) K882380
K882380 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR". The FDA issued a decision of Substantially Equivalent on Oct 6, 1988. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 1988
- Date Received
- Jun 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type
- 510(k)