510(k) K170664
K170664 is an FDA 510(k) premarket notification submitted by Heraeus Medical Components, LLC for the device "Odyssey Micro Catheter". The FDA issued a decision of Substantially Equivalent on Nov 9, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Heraeus Medical Components, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2017
- Date Received
- Mar 6, 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)