510(k) K243691

LiquID .051 LP Guide Catheter Extension by Seigla Medical, Inc. — Product Code DQY

K243691 is an FDA 510(k) premarket notification submitted by Seigla Medical, Inc. for the device "LiquID .051 LP Guide Catheter Extension". The FDA issued a decision of Substantially Equivalent on April 4, 2025. 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
April 4, 2025
Date Received
November 26, 2024
Clearance Type
Special
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