510(k) K963595
K963595 is an FDA 510(k) premarket notification submitted by Cutting Edge Technologies, Inc. for the device "SERAGARD VASCULAR ACCESS DEVICE". The FDA issued a decision of Substantially Equivalent on January 6, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Cutting Edge Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1997
- Date Received
- September 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type