510(k) K142673
- Device
- Bio-Medicus Adult Cannulae And Introducer
- Applicant
- Medtronic, Inc
- 510(k) number
- K142673
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-18
- Date received
- 2014-09-19
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bruce Backlund
- Address
- 8200 Coral Sea St. N.E Mounds View MN US 55112 55112
FDA Registration Numbers#
- 1450019
- 3031571797
- 3005173255
- 3007421149
- 1721676
- 2648988
- 3013267343
- 1423662
- 1319639
- 3011468686
- 1123137
- 1928237
- 1921846
- 8040510
- 3038776570
- 1221051
- 1724474
- 3010155661
- 3010163695
- 3014990448
- 1424263
- 1519227
- 3010017366
- 2244478
- 1423537
- 1831948
- 3007681502
- 3007829657
- 3002807090
- 3030125051
- 3014479313
- 3004080795
- 2011171
- 3003418325
- 1422634
- 3008500478
- 1220648
- 1643817
- 9611665
- 1000393132
- 9680721
- 1319211
- 8010762
- 1043214
- 3009493875
- 1061927
- 3003752502
- 3017540705
- 1723241
- 3019807891
- 2029275
- 2030598
- 3009211636
- 1836324
- 3011554160
- 3016746283
- 1929756
- 2032228
- 1625519
- 3017059666
- 1643116
- 3005448067
- 3021632375
- 9617601
- 2184009
- 1649914
- 1720929
- 1124841
- 1054241
- 1649139
- 1222928
- 3017987980
- 2916596
- 9611109
- 1820334
- 2183744
- 3009380063
- 1047843
- 3009420598
- 3006367242
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | 2026-09-18 |
| K260559 | NHanceIT | IMDS Operation B.V. | 2026-08-14 |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026-08-12 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | 2026-03-13 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
Legacy Summary#
summary
FDA Review#
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