Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select
FDA 510(k) K123153 · Medtronic, Ireland
510(k) numberK123153
Submission
- Device name
- Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select
- Applicant
- Medtronic, Ireland
Galway, IE - Received
- October 9, 2012
- Decision date
- April 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select cleared by the FDA?
Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select (K123153) received a 510(k) decision of Substantially Equivalent on April 9, 2013, 182 days after the submission was received.
What is the product code of K123153?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.