510(k) K113459
- Device
- ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- 510(k) number
- K113459
- Product code
- DWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-29
- Date received
- 2011-11-22
- Regulation
- 870.4210
- Classification name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANNETTE CROOMS
- Address
- 12050 Lone Peak Pkwy. Draper UT US 84020 84020
FDA Registration Numbers#
- 1123137
- 3009211636
- 3010017366
- 3005173255
- 1221051
- 1649139
- 3031571797
- 1222928
- 2011171
- 1643116
- 3007681502
- 1218444
- 1929756
- 3009420598
- 3015173212
- 3014990448
- 3016746283
- 3013267343
- 3011427673
- 1724474
- 2015691
- 1723241
- 3010163695
- 2320762
- 1054241
- 3004080795
- 2183744
- 9611665
- 1124841
- 3017540705
- 1718850
- 1450662
- 8010762
- 1928237
- 3017059666
- 2030598
- 3002807090
- 1319639
- 2024311
- 1647149
- 1424263
- 1043214
- 1319211
- 2916596
- 1820334
- 1836324
- 3011468686
- 1720929
- 3010531069
- 3003418325
- 1450019
- 1921846
- 3018503755
- 9680841
- 1055236
- 1519227
- 1220648
- 3007829657
- 1061927
- 1417592
- 2648988
- 1722746
- 3006367242
- 2029275
- 3007421149
- 1423537
- 8040510
- 3010155661
- 3009380063
- 3008500478
- 2032228
- 1831948
- 3019807891
- 9680721
- 1000523114
- 1721676
- 3021632375
- 3030125051
- 8020347
- 2184009
Source Documents#
Other 510(k) Records For Product Code DWF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | Medtronic, Inc. | 2026-04-23 |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | 2026-03-11 |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | 2026-02-23 |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | 2026-02-19 |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-01-30 |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 2026-01-20 |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | 2025-10-24 |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | 2025-07-10 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025-06-27 |
| K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | Medtronic, Inc. | 2025-06-20 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | 2024-05-31 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Sorin Group Italia S.R.L. | 2024-02-22 |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | Edwards Lifesciences | 2024-02-05 |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-12-07 |
| K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-05-04 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases