510(k) K220691
K220691 is an FDA 510(k) premarket notification submitted by Seigla Medical, Inc. for the device "LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension". The FDA issued a decision of Substantially Equivalent on May 5, 2022. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Seigla Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2022
- Date Received
- March 9, 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