510(k) K180169
- Device
- EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm And 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035
- Applicant
- Imperative Care Inc.
- 510(k) number
- K180169
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-08
- Date received
- 2018-01-22
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jake Wolenberg
- Address
- 1221 Innsbruck Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 1123137
- 3009121749
- 3012543881
- 3016829855
- 3006451981
- 3021951050
- 3011142981
- 3032916632
- 2953200
- 3010370269
- 2183870
- 1018233
- 2134265
- 9680794
- 3004091615
- 3007882731
- 3005580113
- 1625425
- 2011171
- 3012279212
- 1061124
- 3000126629
- 2648729
- 3012307300
- 3020677060
- 3009018440
- 3010041511
- 3006131984
- 3008110587
- 2017233
- 2182269
- 3013162291
- 3010432890
- 3009756153
- 3017708755
- 3016522967
- 3015859709
- 3012536737
- 3001374820
- 3004111573
- 3009965866
- 1000121056
- 3014779787
- 2939561
- 3015453963
- 3008824097
- 3009905888
- 1318694
- 2030624
- 2024168
- 3004415014
- 1724474
- 3015615738
- 3025341484
- 3033589330
- 3012154226
- 3013764800
- 8010026
- 8023054
- 3001124136
- 1064858
- 3016704395
- 3020950818
- 2124215
- 3012497308
- 2183744
- 3005718570
- 2126666
- 3015002281
- 3005334138
- 3008261722
- 2027111
- 9610139
- 1450662
- 3008307705
- 1028232
- 3006550224
- 3015053858
- 3005994106
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 |
Legacy Summary#
summary
FDA Review#
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