510(k) K981547
K981547 is an FDA 510(k) premarket notification submitted by Filtertek, Inc. for the device "NFC NEEDLEFREE Y-SITE, MODEL 69970". The FDA issued a decision of Substantially Equivalent on June 18, 1998. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Filtertek, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 1998
- Date Received
- April 30, 1998
- 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