510(k) K813268
K813268 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SC-2500F CARDIOTOMY RESERVIOR". The FDA issued a decision of Substantially Equivalent on May 18, 1982. 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
- May 18, 1982
- Date Received
- Nov 20, 1981
- 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)