510(k) K171146
K171146 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary Of Telelflex Inc.) for the device "Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2017
- Date Received
- Apr 19, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)