K983927 is an FDA 510(k) clearance for the GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT. This device is classified as a Occluder, Catheter Tip (Class II - Special Controls, product code DQT).
Submitted by Arterial Vascular Engineering, Inc. (Billerica, US). The FDA issued a Cleared decision on March 11, 1999, 126 days after receiving the submission on November 5, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1370.
| 510(k) Number | K983927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1998 |
| Decision Date | March 11, 1999 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQT — Occluder, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1370 |