510(k) K153423
K153423 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) for the device "CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC". The FDA issued a decision of Substantially Equivalent on January 28, 2016. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2016
- Date Received
- November 25, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type