510(k) K002471
K002471 is an FDA 510(k) premarket notification submitted by Pfm Produkte Fur Die Medizin AG for the device "JETCAN HUBER NEEEDLE SET". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pfm Produkte Fur Die Medizin AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2000
- Date Received
- August 11, 2000
- 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