Atlas FDA

ADVANTA GRAFT (>6MM)

FDA 510(k) clearance K992960 · decided 1999-10-01

Clearance details

K-number
K992960
Device name
ADVANTA GRAFT (>6MM)
Applicant
Atrium Medical Corp.
Decision
Substantially Equivalent
Date received
1999-09-02
Decision date
1999-10-01
Days to decision
29 days
Clearance type
Special
Product code
DSY
Device class
2
Regulation number
870.3450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Hudson, NH, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Gelsoft™ Plus Vascular Prostheses (K241070)Vascutek, Ltd.2024-11-15
Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972)Atrium Medical Corporation2024-03-28
GORE® PROPATEN® Vascular Graft (K240083)W. L. Gore & Associates, Inc.2024-03-01
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783)Peca Labs, Inc.2024-01-17
GORE® PROPATEN® Vascular Graft (K232312)W. L. Gore & Associates, Inc.2024-01-09
GORE® ACUSEAL Vascular Graft (K233551)W. L. Gore & Associates, Inc.2023-12-19
GORE® ACUSEAL Vascular Graft (K231505)W. L. Gore & Associates, Inc.2023-06-23
HeRO Graft (K213845)Merit Medical Systems, Inc.2022-08-15
exGraft, exGraft Carbon (K221628)Peca Labs2022-08-04

Recalls involving this device

RecordFirmDate
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1952-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1953-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1955-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1956-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1957-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1959-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1960-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft recall (Z-1961-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1963-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1965-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1966-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1967-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1968-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1969-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1970-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1971-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1972-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1973-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1974-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1975-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1976-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1977-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1978-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1979-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1980-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1981-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1982-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1983-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1984-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1985-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1986-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1987-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1988-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1989-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1990-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft recall (Z-1991-2024)Atrium Medical Corporation2024-06-04
ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft recall (Z-1992-2024)Atrium Medical Corporation2024-06-04
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, recall (Z-2304-2013)Atrium Medical Corporation2013-09-30

PMA approvals by this applicant

RecordFirmDate
iCast Covered Stent System (P120003/S009)Atrium Medical Corp.2025-12-22
iCast Covered Stent System (P120003/S011)Atrium Medical Corp.2025-09-12
iCast Covered Stent System (P120003/S010)Atrium Medical Corp.2025-08-20
iCast Covered Stent System (P120003/S006)Atrium Medical Corp.2025-07-07
iCast Covered Stent System (P120003/S008)Atrium Medical Corp.2025-05-01
iCast Covered Stent System (P120003/S005)Atrium Medical Corp.2024-08-07
iCast Covered Stent System (P120003/S004)Atrium Medical Corp.2024-07-24
iCast Covered Stent System (P120003/S003)Atrium Medical Corp.2023-10-18