Atlas FDA

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

FDA 510(k) clearance K161596 · decided 2017-04-28

Clearance details

K-number
K161596
Device name
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
Applicant
AngioDynamics, Inc.
Decision
Substantially Equivalent
Date received
2016-06-09
Decision date
2017-04-28
Days to decision
323 days
Clearance type
Traditional
Product code
DQO
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Queensburgy, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Ca recall (Z-1856-2026)Angiodynamics, Inc.2026-04-17
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Cata recall (Z-1857-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; C recall (Z-1858-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Cat recall (Z-1859-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; recall (Z-1860-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; C recall (Z-1861-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catal recall (Z-1862-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; recall (Z-1863-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; recall (Z-1864-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; recall (Z-1865-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Cata recall (Z-1866-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM recall (Z-1867-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB recall (Z-1868-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB recall (Z-1869-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; C recall (Z-1870-2026)Angiodynamics, Inc.2026-04-17
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catal recall (Z-1871-2026)Angiodynamics, Inc.2026-04-17
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X recall (Z-1872-2026)Angiodynamics, Inc.2026-04-17
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU ST recall (Z-1873-2026)Angiodynamics, Inc.2026-04-17
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F recall (Z-1874-2026)Angiodynamics, Inc.2026-04-17
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 7 recall (Z-1875-2026)Angiodynamics, Inc.2026-04-17