510(k) K190749
K190749 is an FDA 510(k) premarket notification submitted by Q'Apel for the device "087 Balloon Guide Catheter System". The FDA issued a decision of Substantially Equivalent on Jul 15, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Q'Apel has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 2019
- Date Received
- Mar 25, 2019
- 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)