510(k) K132995
- Device
- DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
- Applicant
- MEDTRONIC INC.
- 510(k) number
- K132995
- Product code
- DWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-31
- Date received
- 2013-09-24
- Regulation
- 870.4210
- Classification name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHELSEA PIOSKE
- Address
- 7611 Northland Dr. Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 3003752502
- 1221051
- 3007421149
- 3005941719
- 3009380063
- 1220948
- 3045042524
- 3011554160
- 2030598
- 3017987980
- 3002807090
- 3031571797
- 1929756
- 1319639
- 1718850
- 3007681502
- 3011427673
- 3005173255
- 3013267343
- 1220648
- 1450019
- 3010155661
- 1721676
- 2183744
- 1724474
- 1928237
- 1319211
- 3008500478
- 2024311
- 9680841
- 1643116
- 1218444
- 8010762
- 3038776570
- 3018503755
- 3014479313
- 1519227
- 1820334
- 2320762
- 1720929
- 3030125051
- 1723241
- 1649914
- 1123137
- 1000393132
- 1422634
- 3005448067
- 1625519
- 3006367242
- 8040510
- 2648988
- 1043214
- 3008998256
- 1423662
- 1424263
- 1423537
- 3003955307
- 1450662
- 3021632375
- 1643817
- 1649139
- 8020347
- 3014990448
- 1921846
- 2916596
- 1055236
- 2011171
- 3011468686
- 1124841
- 3009493875
- 9611665
- 3004080795
- 1417592
- 3016746283
- 1836324
- 3010163695
- 1222928
- 3010017366
- 9611109
Source Documents#
Other 510(k) Records For Product Code DWF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263076 | AngioVac F1885 | AngioDynamics, Inc. | 2026-10-30 |
| K263596 | DLP™ Coronary Ostial Cannulae | Medtronic, Inc. | 2026-10-29 |
| K263092 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-10-01 |
| K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-09-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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