510(k) K171146
- Device
- Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga.
- Applicant
- Arrow International, Inc. (Subsidiary Of Telelflex Inc.)
- 510(k) number
- K171146
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-23
- Date received
- 2017-04-19
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Fallon Young
- Address
- 2400 Bernville Rd. Reading PA US 19605 19605
FDA Registration Numbers#
- 3016948450
- 3014461810
- 9618000
- 8023054
- 3009018440
- 3007882731
- 2648045
- 3006260740
- 3004784537
- 3007628272
- 3001124136
- 3012159165
- 3006942602
- 3017278832
- 3003910212
- 1828132
- 1820334
- 3008853977
- 1000121056
- 1220477
- 3020954746
- 3004091615
- 1018470
- 3007007790
- 9612164
- 3005255160
- 3011088743
- 3013557562
- 1313046
- 3006550224
- 3005718570
- 3004718255
- 3032916632
- 1048735
- 3014498720
- 3012179728
- 2134812
- 3009756153
- 3012102437
- 3004063494
- 3016678045
- 3013944123
- 3002806603
- 3005070406
- 3011142981
- 2020735
- 3013134719
- 3009121749
- 3006082230
- 3009766315
- 3012543881
- 3012050423
- 3031311812
- 3009380063
- 3012497308
- 3008573567
- 3000247873
- 3009756327
- 3014779787
- 3024801436
- 3008110587
- 9680794
- 2011171
- 1220452
- 2183870
- 3012266672
- 3007207906
- 3016522967
- 1722746
- 3025341484
- 3044156918
- 3001374820
- 3010909876
- 2029214
- 3004742232
- 3012279212
- 9614654
- 3003915875
- 3014766734
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
Legacy Summary#
summary
FDA Review#
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