Agills PF Delivery System
FDA 510(k) K111943 · St. Jude Medical, Cardiac Rhythm Management Divisi
510(k) numberK111943
Submission
- Device name
- Agills PF Delivery System
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
Sylmar, CA, US - Received
- July 8, 2011
- Decision date
- September 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Agills PF Delivery System cleared by the FDA?
Agills PF Delivery System (K111943) received a 510(k) decision of Substantially Equivalent on September 29, 2011, 83 days after the submission was received.
What is the product code of K111943?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.