510(k) K890113
K890113 is an FDA 510(k) premarket notification submitted by Cardiovascular Devices, Inc. for the device "THE CDI(R) SYSTEM 400". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. Cardiovascular Devices, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1989
- Date Received
- January 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ion-Exchange Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type