510(k) K152090
K152090 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "Reprocessed Steerable Introducer". The FDA issued a decision of Substantially Equivalent on March 23, 2016. The device falls under product code PNE (Reprocessed Catheter Introducer), a Class II device regulated under 21 CFR 870.1340. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2016
- Date Received
- July 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reprocessed Catheter Introducer
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
Introduce various cardiovascular catheters into the heart and cardiovascular system