GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT— 510(k) K983927
Substantially EquivalentArterial Vascular Engineering, Inc.
FDA 510(k) clearance K983927 for GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT, Substantially Equivalent on 1999-03-11. Applicant: Arterial Vascular Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- Arterial Vascular Engineering, Inc.
- Product code
- Code DQT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Recent devices under product code DQT
view allMore clearances from Arterial Vascular Engineering, Inc.
view allRecalls naming K983927
K-number listed on FDA's recall record- Z-0262-2014 — Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
- Z-0268-2014 — ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983927.
Data sourced from openFDA. This site is unofficial and independent of the FDA.