Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag
FDA 510(k) K101186 · Medtronic Perfusion Systems
510(k) numberK101186
Submission
- Device name
- Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag
- Applicant
- Medtronic Perfusion Systems
Minneapolis, MN, US - Received
- April 28, 2010
- Decision date
- September 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTP – Defoamer, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4230
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag cleared by the FDA?
Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag (K101186) received a 510(k) decision of Substantially Equivalent on September 3, 2010, 128 days after the submission was received.
What is the product code of K101186?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.