510(k) K030398
K030398 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221". The FDA issued a decision of Substantially Equivalent on May 23, 2003. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2003
- Date Received
- February 6, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1300
- Review Panel
- CV
- Submission Type