510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983927Substantially Equivalent

Gt1 Floppy, Gt1 Hi-per Flex, Gt1 Light Support

Arterial Vascular Engineering, Inc., Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983927 is the FDA 510(k) clearance record for GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT, a class II device, cleared for Arterial Vascular Engineering, Inc. on under FDA product code DQT (Occluder, Catheter Tip). FDA records list 3 510(k) clearances for Arterial Vascular Engineering, Inc., from to . As of , FDA records show 2 recalls naming K983927.

Clearance record

Decision date
Received
(126 days to decision)
Product code
DQT Occluder, Catheter Tip
Regulation
21 CFR 870.1370
Device class
Class II
Review panel
Cardiovascular
Applicant
Arterial Vascular Engineering, Inc. 129 Concord Rd., Billerica MA
510(k) summary
Summary
Third party review
No

Clearances, product code DQT

Trailing 12 months

FDA records hold no clearances under product code DQT in the trailing twelve months.

FDA records show no clearances under product code DQT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260