510(k) K242763

JetCan® Pro Safety Huber Needle by Pfm Medical, Inc. — Product Code FPA

K242763 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "JetCan® Pro Safety Huber Needle". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
September 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type