Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B
FDA 510(k) K003724 · Medtronic Vascular
510(k) numberK003724
Submission
- Device name
- Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- December 4, 2000
- Decision date
- December 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B cleared by the FDA?
Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B (K003724) received a 510(k) decision of Substantially Equivalent on December 21, 2000, 17 days after the submission was received.
What is the product code of K003724?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.