CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
FDA 510(k) K092075 · St. Jude Medical, Cardiac Rhythm Management Divisi
510(k) numberK092075
Submission
- Device name
- CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
Sylmar, CA, US - Received
- July 9, 2009
- Decision date
- August 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 cleared by the FDA?
CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (K092075) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 29 days after the submission was received.
What is the product code of K092075?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.