510(k) K171176
K171176 is an FDA 510(k) premarket notification submitted by Acrostak (Schweiz) AG for the device "M-CATH Microcatheter". The FDA issued a decision of Substantially Equivalent on Sep 15, 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
- Sep 15, 2017
- Date Received
- Apr 21, 2017
- Clearance Type
- Traditional
- 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)