Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2026 | Boston Scientific Corporation Imager II Angiographic Catheters
M001314001
IMAGER II/5/ST/65/038 BX5;
M001314011
IMAGER II/5/ST/100/038 BX5;
M001314021
IMAGER II/5/ST/65/035 BX 5;
M001314031
IMAGER II/5/ST/100/035 BX 5;
M00131 Open, Classified |
DQO | K121694 |
| May 1, 2026 | Cook Incorporated Beacon Tip Centimeter Sizing Catheter
RPN/GPN
NR5.0-35-70-P-10S-0-CSC-20
G31213
NR5.0-35-100-P-10S-0-CSC-20
G31214
NR5.0-35-100-P-10S-PIG-CSC-20
G31216
NR5.0-35-70-P-10S-VCF-CSC-20
G31220
NR5.0-35-100 Open, Classified |
DQO | K173289 |
| May 1, 2026 | Cook Incorporated Aurous Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20-01
GPN G47308
Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic Open, Classified |
DQO | K162448 |
| May 1, 2026 | Cook Incorporated Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20
GPN G11916
Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and d 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 | K112452 K161596 |
| 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 | K112452 K161596 |
| 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 | K112452 K161596 |
| 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 | K112452 K161596 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K112452 K161596 +1 |
| 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 | K161596 K173762 |
| 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 | K112452 K161596 +1 |
| Apr 16, 2026 | Gentuity, LLC Gentuity HF-OCT Imaging System Model G10-01;
Software version 23.2.13; Open, Classified |
DQO | K242966 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 Open, Classified |
DQO | K180846 |
| Jun 16, 2025 | Cook Incorporated Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft len Open, Classified |
DQO | K173289 |
| Jul 31, 2024 | Angiodynamics, Inc. SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.
Catalog Number: 10732701 Open, Classified |
DQO | K173762 |
| Jul 31, 2024 | Angiodynamics, Inc. SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.
Catalog Number: 10732702 Open, Classified |
DQO | K173762 |
| May 28, 2024 | Stryker Neurovascular Trevo Pro 14 Microcatheter, Catalog: 90231;
Trevo Pro 18 Microcatheter, Catalog: 90238 Open, Classified |
DQO | K113260 K131437 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter Open, Classified |
DQO | K152605 |
| May 10, 2024 | Boston Scientific Corporation Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter Open, Classified |
DQO | K152605 |
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