510(k) K963972
K963972 is an FDA 510(k) premarket notification submitted by Klein-Baker Medical, Inc. for the device "NEO-CARE DUAL LUMEN UMBILICAL CATHETER". The FDA issued a decision of Substantially Equivalent on December 24, 1996. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Klein-Baker Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 1996
- Date Received
- October 3, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Umbilical Artery
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type