510(k) K220331
K220331 is an FDA 510(k) premarket notification submitted by Inneuroco, Inc. for the device "091 Balloon Guide Catheter". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Inneuroco, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2022
- Date Received
- February 4, 2022
- 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