510(k) K983927
K983927 is an FDA 510(k) premarket notification submitted by Arterial Vascular Engineering, Inc. for the device "GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT". The FDA issued a decision of Substantially Equivalent on March 11, 1999. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Arterial Vascular Engineering, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1999
- Date Received
- November 5, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Occluder, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.1370
- Review Panel
- CV
- Submission Type