Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia System
FDA 510(k) K012763 · Cobe Cardiovascular, Inc.
510(k) numberK012763
Submission
- Device name
- Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia System
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- August 17, 2001
- Decision date
- November 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K040184 | Dideco Micro 40 Ph.I.S.I.O. Adult Arterial FilterDTM · Special | 02/26/2004SE |
| K033641 | Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800DTN · Special | 12/11/2003SE |
| K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700KFM · Special | 03/06/2003SE |
| K021830 | Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemDTR · Special | 07/02/2002SE |
| K011835 | Cobe RevolutionKFM · Abbreviated | 02/12/2002SE |
| K013480 | Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Special | 11/16/2001SE |
| K001509 | Stockert V172 Series Venous Femoral CannulaeDWF · Abbreviated | 10/26/2001SE |
| K012898 | Modification to: CSC14 Blood Cardioplegia SystemDTR · Special | 09/17/2001SE |
Questions and answers
When was Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia System cleared by the FDA?
Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia System (K012763) received a 510(k) decision of Substantially Equivalent on November 15, 2001, 90 days after the submission was received.
What is the product code of K012763?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.