510(k) K924529
K924529 is an FDA 510(k) premarket notification submitted by Avecor Cardiovascular, Inc. for the device "SIGNATURE(TM) CUSTOM TUBING PACK". The FDA issued a decision of Substantially Equivalent (kit) on June 23, 1993. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Avecor Cardiovascular, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- June 23, 1993
- Date Received
- September 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type