510(k) K151667
- Device
- AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
- Applicant
- Stryker
- 510(k) number
- K151667
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-13
- Date received
- 2015-06-19
- 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
- Rhoda M Santos
- Address
- 47900 Bayside Pkwy. Fremont CA US 94538 94538
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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