BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208
FDA 510(k) K122587 · St Jude Medical
510(k) numberK122587
Submission
- Device name
- BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208
- Applicant
- St Jude Medical
Minnetonka, MN, US - Received
- August 24, 2012
- Decision date
- February 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 cleared by the FDA?
BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 (K122587) received a 510(k) decision of Substantially Equivalent on February 7, 2013, 167 days after the submission was received.
What is the product code of K122587?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.