510(k) K131446
K131446 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES". The FDA issued a decision of Substantially Equivalent on October 28, 2013. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2013
- Date Received
- May 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1300
- Review Panel
- CV
- Submission Type