510(k) K003288
K003288 is an FDA 510(k) premarket notification submitted by Origen Biomedical, Inc. for the device "ORIGEN DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Origen Biomedical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2001
- Date Received
- October 20, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type