St. Jude Medical, CPS Duo Left Heart Lead Delivery System
FDA 510(k) K072864 · St. Jude Medical, Cardiac Rhythm Management Divisi
510(k) numberK072864
Submission
- Device name
- St. Jude Medical, CPS Duo Left Heart Lead Delivery System
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
Sylmar, CA, US - Received
- October 5, 2007
- Decision date
- March 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
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| K092075 | CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004…DQY · Special | 08/07/2009SE |
| K090613 | CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59…DQY · Special | 07/01/2009SE |
| K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional | 04/30/2008SE |
Questions and answers
When was St. Jude Medical, CPS Duo Left Heart Lead Delivery System cleared by the FDA?
St. Jude Medical, CPS Duo Left Heart Lead Delivery System (K072864) received a 510(k) decision of Substantially Equivalent on March 13, 2008, 160 days after the submission was received.
What is the product code of K072864?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.