510(k) K161596 ยท DQO Catheter, Intravascular, Diagnostic
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Jun 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Pigtail, Non-Braided;
SOFT-VU PT 4F X 100CM 035 NB 10SH;
Catalog No.: 10707103;
Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch);
Box Quantity: 10; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft -Vu Angiographic Catheter, Kumpe, Non-Braided;
SOFT-VU KMP 4F X 40CM 038 NB 0SH;
Catalog No.: 10710013;
Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided;
SOFT-VU OF 4F X 65CM 038 NB 6SH;
Catalog No.: 10714001;
Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch);
Box Quantity: 10 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Pigtail, Non-Braided;
SOFT-VU PT 4F X 65CM 038 NB 10SH;
Catalog No.: 10714002;
Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch);
Box Quantity: 10 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;
SOFT-VU BER 4F X 65CM 038 NB 0SH;
Catalog No.: 10714009;
Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided;
SOFT-VU CB2 4F X 65CM 038 NB 0SH;
Catalog No.: 10714011;
Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided;
SOFT-VU KMP 4F X 65CM 038 NB 0SH;
Catalog No.: 10714014;
Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;
SOFT-VU BER 4F X 100CM 038 NB 0SH;
Catalog No.: 10714016;
Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided;
SOFT-VU CB1 4F X 100CM 038 NB 0SH;
Catalog No.: 10714017;
Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided;
SOFT-VU CB2 4F X 100CM 038 NB 0SH;
Catalog No.: 10714018;
Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided;
SOFT-VU KMP 4F X 100CM 038 NB 0SH;
Catalog No.: 10714021;
Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided;
SOFT-VU SO1 4F X 80CM 038 NB 0SH;
Catalog No.: 10714024;
Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch);
Box Quantity: Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided;
SOFT-VU HH1 4F X 100CM 038 NB 0SH;
Catalog No.: 10714040;
Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch);
Box Quantity: 5 pouch Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Straight Art, Non-Braided;
SOFT-VU STR ART 4F X 65CM 035 NB 0SH;
Catalog No.: 10731401;
Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch);
Box Quantity: 5 pouc Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided;
SOFT-VU OF 4F X 65CM 035 NB 6SH;
Catalog No.: 10732301;
Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch);
Box Quantity: 10 units; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Kumpe, Non-Braided;
SOFT-VU KMP 4F X 40CM 035 NB 0SH;
Catalog No.: 10734301;
Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch);
Box Quantity: 5 pouches; Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers;
ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM;
Catalog No.: 13709005;
Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch) Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers;
ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM;
Catalog No.: 13709604;
Product/UPN No.: H787137096045 (Box), H7 Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers;
ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM;
Catalog No.: 13709704;
Product/UPN No.: H787137097045 (Box), H787137097040 (Pouc Open, Classified |
DQO | None listed |
| Apr 17, 2026 | Angiodynamics, Inc. AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers;
ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM;
Catalog No.: 13709804;
Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch) Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.