ADVANTA GRAFT (<6MM)— 510(k) K992958

Name: FDA 510(k) clearance K992958
Creator: U.S. Food and Drug Administration
Published: 1999-10-01

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K992958 for ADVANTA GRAFT (<6MM), Substantially Equivalent on 1999-10-01. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code DYF
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1999-09-02
Decision date: 1999-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K992958

K-number listed on FDA's recall record

Z-1951-2024 — ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1954-2024 — ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1958-2024 — ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1962-2024 — ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1964-2024 — ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1993-2024 — ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1994-2024 — ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1995-2024 — ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1996-2024 — ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1997-2024 — ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1998-2024 — ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-1999-2024 — ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-2000-2024 — ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-2001-2024 — ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graftClass II·Ongoing·Atrium Medical Corporation·20240503
Z-2313-2013 — Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Class II·Terminated·Atrium Medical Corporation·20130712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992958.

Data sourced from openFDA. This site is unofficial and independent of the FDA.